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Review
. 2023 Jun 2;6(6):CD004197.
doi: 10.1002/14651858.CD004197.pub6.

Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis

Simon C Langton Hewer  1   2 , Sherie Smith  3 , Nicola J Rowbotham  3 , Alexander Yule  3 , Alan R Smyth  3
Affiliations
Review

Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis

Simon C Langton Hewer et al. Cochrane Database Syst Rev. .

Abstract

Background: Respiratory tract infections with Pseudomonas aeruginosa occur in most people with cystic fibrosis (CF). Established chronic P aeruginosa infection is virtually impossible to eradicate and is associated with increased mortality and morbidity. Early infection may be easier to eradicate. This is an updated review.

Objectives: Does giving antibiotics for P aeruginosa infection in people with CF at the time of new isolation improve clinical outcomes (e.g. mortality, quality of life and morbidity), eradicate P aeruginosa infection, and delay the onset of chronic infection, but without adverse effects, compared to usual treatment or an alternative antibiotic regimen? We also assessed cost-effectiveness.

Search methods: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and conference proceedings. Latest search: 24 March 2022. We searched ongoing trials registries. Latest search: 6 April 2022.

Selection criteria: We included randomised controlled trials (RCTs) of people with CF, in whom P aeruginosa had recently been isolated from respiratory secretions. We compared combinations of inhaled, oral or intravenous (IV) antibiotics with placebo, usual treatment or other antibiotic combinations. We excluded non-randomised trials and cross-over trials.

Data collection and analysis: Two authors independently selected trials, assessed risk of bias and extracted data. We assessed the certainty of the evidence using GRADE.

Main results: We included 11 trials (1449 participants) lasting between 28 days and 27 months; some had few participants and most had relatively short follow-up periods. Antibiotics in this review are: oral - ciprofloxacin and azithromycin; inhaled - tobramycin nebuliser solution for inhalation (TNS), aztreonam lysine (AZLI) and colistin; IV - ceftazidime and tobramycin. There was generally a low risk of bias from missing data. In most trials it was difficult to blind participants and clinicians to treatment. Two trials were supported by the manufacturers of the antibiotic used. TNS versus placebo TNS may improve eradication; fewer participants were still positive for P aeruginosa at one month (odds ratio (OR) 0.06, 95% confidence interval (CI) 0.02 to 0.18; 3 trials, 89 participants; low-certainty evidence) and two months (OR 0.15, 95% CI 0.03 to 0.65; 2 trials, 38 participants). We are uncertain whether the odds of a positive culture decrease at 12 months (OR 0.02, 95% CI 0.00 to 0.67; 1 trial, 12 participants). TNS (28 days) versus TNS (56 days) One trial (88 participants) comparing 28 days to 56 days TNS treatment found duration of treatment may make little or no difference in time to next isolation (hazard ratio (HR) 0.81, 95% CI 0.37 to 1.76; low-certainty evidence). Cycled TNS versus culture-based TNS One trial (304 children, one to 12 years old) compared cycled TNS to culture-based therapy and also ciprofloxacin to placebo. We found moderate-certainty evidence of an effect favouring cycled TNS therapy (OR 0.51, 95% CI 0.31 to 0.82), although the trial publication reported age-adjusted OR and no difference between groups. Ciprofloxacin versus placebo added to cycled and culture-based TNS therapy One trial (296 participants) examined the effect of adding ciprofloxacin versus placebo to cycled and culture-based TNS therapy. There is probably no difference between ciprofloxacin and placebo in eradicating P aeruginosa (OR 0.89, 95% CI 0.55 to 1.44; moderate-certainty evidence). Ciprofloxacin and colistin versus TNS We are uncertain whether there is any difference between groups in eradication of P aeruginosa at up to six months (OR 0.43, 95% CI 0.15 to 1.23; 1 trial, 58 participants) or up to 24 months (OR 0.76, 95% CI 0.24 to 2.42; 1 trial, 47 participants); there was a low rate of short-term eradication in both groups. Ciprofloxacin plus colistin versus ciprofloxacin plus TNS One trial (223 participants) found there may be no difference in positive respiratory cultures at 16 months between ciprofloxacin with colistin versus TNS with ciprofloxacin (OR 1.28, 95% CI 0.72 to 2.29; low-certainty evidence). TNS plus azithromycin compared to TNS plus oral placebo Adding azithromycin may make no difference to the number of participants eradicating P aeruginosa after a three-month treatment phase (risk ratio (RR) 1.01, 95% CI 0.75 to 1.35; 1 trial, 91 participants; low-certainty evidence); there was also no evidence of any difference in the time to recurrence. Ciprofloxacin and colistin versus no treatment A single trial only reported one of our planned outcomes; there were no adverse effects in either group. AZLI for 14 days plus placebo for 14 days compared to AZLI for 28 days We are uncertain whether giving 14 or 28 days of AZLI makes any difference to the proportion of participants having a negative respiratory culture at 28 days (mean difference (MD) -7.50, 95% CI -24.80 to 9.80; 1 trial, 139 participants; very low-certainty evidence). Ceftazidime with IV tobramycin compared with ciprofloxacin (both regimens in conjunction with three months colistin) IV ceftazidime with tobramycin compared with ciprofloxacin may make little or no difference to eradication of P aeruginosa at three months, sustained to 15 months, provided that inhaled antibiotics are also used (RR 0.84, 95 % CI 0.65 to 1.09; P = 0.18; 1 trial, 255 participants; high-certainty evidence). The results do not support using IV antibiotics over oral therapy to eradicate P aeruginosa, based on both eradication rate and financial cost.

Authors' conclusions: We found that nebulised antibiotics, alone or with oral antibiotics, were better than no treatment for early infection with P aeruginosa. Eradication may be sustained in the short term. There is insufficient evidence to determine whether these antibiotic strategies decrease mortality or morbidity, improve quality of life, or are associated with adverse effects compared to placebo or standard treatment. Four trials comparing two active treatments have failed to show differences in rates of eradication of P aeruginosa. One large trial showed that intravenous ceftazidime with tobramycin is not superior to oral ciprofloxacin when inhaled antibiotics are also used. There is still insufficient evidence to state which antibiotic strategy should be used for the eradication of early P aeruginosa infection in CF, but there is now evidence that intravenous therapy is not superior to oral antibiotics.

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Conflict of interest statement

Dr Langton Hewer is the lead investigator on the included trial Torpedo‐CF: Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis, a multicentre study funded by the UK National Institute for Health & Care Research and published in Lancet Respiratory Medicine. He has also received speaker fees from Vertex Pharmaceuticals (this company does not manufacture any drugs that might be eligible for consideration in this review).

Dr Nicola J Rowbotham declares no potential conflict of interest.

Mrs Sherie Smith declares no potential conflict of interest.

Dr Alex Yule declares he is currently a clinical research fellow working on the GIFT‐CF3 Study (NCT04618185). This study has received funding from Vertex Pharmaceuticals (who do not manufacture any drugs that might be eligible for consideration in this review).

Prof. Smyth declares he holds a patent for alkyl quinolones as biomarkers of Pseudomonas aeruginosa infection and uses thereof (not relevant to any intervention included in this review); he also declares holding a research grant from Vertex Pharmaceuticals (company does not produce any relevant medication for this review). Prof. Smyth is joint chief investigator on the published trial 'Torpedo‐CF: Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis' which is included in this review.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 1: Positive respiratory culture for P aeruginosa (300 mg 2x daily)
1.2
1.2. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 2: Positive respiratory culture for P aeruginosa (80 mg 2x daily)
1.3
1.3. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 3: Positive respiratory culture for P aeruginosa (combined available case analysis)
1.4
1.4. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 4: Positive respiratory culture for P aeruginosa (combined) ‐ best case
1.5
1.5. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 5: Positive respiratory culture for P aeruginosa (combined) ‐ worst case
1.6
1.6. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 6: Weight (kg) ‐ change from baseline
1.7
1.7. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 7: Adverse events
1.8
1.8. Analysis
Comparison 1: Inhaled tobramycin (TNS) versus placebo, Outcome 8: Modified Shwachmann score ‐ change from baseline
2.1
2.1. Analysis
Comparison 2: Inhaled tobramycin (TNS) 28 days versus 56 days, Outcome 1: Time to next isolation of P aeruginosa from BAL, sputum or oropharyngeal cultures
2.2
2.2. Analysis
Comparison 2: Inhaled tobramycin (TNS) 28 days versus 56 days, Outcome 2: Number of respiratory exacerbations
2.3
2.3. Analysis
Comparison 2: Inhaled tobramycin (TNS) 28 days versus 56 days, Outcome 3: Adverse events (up to 3 months)
2.4
2.4. Analysis
Comparison 2: Inhaled tobramycin (TNS) 28 days versus 56 days, Outcome 4: Adverse events (over 3 months)
3.1
3.1. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 1: Participants with one or more isolates of P aeruginosa from respiratory tract
3.2
3.2. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 2: FEV₁ % predicted ‐ change from baseline
3.3
3.3. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 3: Weight (kg) ‐ change from baseline
3.4
3.4. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 4: Height (cm) ‐ change from baseline
3.5
3.5. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 5: Time to severe pulmonary exacerbation
3.6
3.6. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 6: Participants with one or more severe pulmonary exacerbations
3.7
3.7. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 7: Time to pulmonary exacerbation (any severity)
3.8
3.8. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 8: Participants with one or more pulmonary exacerbations (any severity)
3.9
3.9. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 9: Participants with new isolates of Stenotrophomonas maltophilia
3.10
3.10. Analysis
Comparison 3: Cycled inhaled tobramycin (TNS) versus culture‐based TNS, Outcome 10: Participants with one or more serious adverse event
4.1
4.1. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 1: Participants with one or more isolates of P aeruginosa from respiratory tract
4.2
4.2. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 2: FEV₁ % predicted ‐ change from baseline
4.3
4.3. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 3: Weight (kg) ‐ change from baseline
4.4
4.4. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 4: Height (cm) ‐ change from baseline
4.5
4.5. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 5: Time to severe pulmonary exacerbation
4.6
4.6. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 6: Participants with one or more severe pulmonary exacerbations
4.7
4.7. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 7: Time to pulmonary exacerbation (any severity)
4.8
4.8. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 8: Participants with one of more pulmonary exacerbation (any severity)
4.9
4.9. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 9: Participants with new isolates of Stenotrophomonas maltophilia
4.10
4.10. Analysis
Comparison 4: Ciprofloxacin versus placebo added to cycled and culture‐based inhaled tobramycin (TNS), Outcome 10: Participants with one or more serious adverse event
5.1
5.1. Analysis
Comparison 5: Oral ciprofloxacin and inhaled colistin versus inhaled tobramycin (TNS), Outcome 1: Positive respiratory culture for P aeruginosa
5.2
5.2. Analysis
Comparison 5: Oral ciprofloxacin and inhaled colistin versus inhaled tobramycin (TNS), Outcome 2: Adverse events
6.1
6.1. Analysis
Comparison 6: Inhaled colistin plus oral ciprofloxacin versus inhaled tobramycin (TNS) plus oral ciprofloxacin, Outcome 1: Positive respiratory culture for P aeruginosa
6.2
6.2. Analysis
Comparison 6: Inhaled colistin plus oral ciprofloxacin versus inhaled tobramycin (TNS) plus oral ciprofloxacin, Outcome 2: FEV₁ % predicted (relative change from baseline)
6.3
6.3. Analysis
Comparison 6: Inhaled colistin plus oral ciprofloxacin versus inhaled tobramycin (TNS) plus oral ciprofloxacin, Outcome 3: Microbiology status (post‐trial)
6.4
6.4. Analysis
Comparison 6: Inhaled colistin plus oral ciprofloxacin versus inhaled tobramycin (TNS) plus oral ciprofloxacin, Outcome 4: Adverse events leading to trial discontinuation
7.1
7.1. Analysis
Comparison 7: Inhaled tobramycin (TNS) plus oral azithromycin versus TNS plus oral placebo, Outcome 1: Eradication of PA after first treatment quarter
7.2
7.2. Analysis
Comparison 7: Inhaled tobramycin (TNS) plus oral azithromycin versus TNS plus oral placebo, Outcome 2: Number of participants experiencing an exacerbation
7.3
7.3. Analysis
Comparison 7: Inhaled tobramycin (TNS) plus oral azithromycin versus TNS plus oral placebo, Outcome 3: Number of participants requiring additional antibiotics during the study
7.4
7.4. Analysis
Comparison 7: Inhaled tobramycin (TNS) plus oral azithromycin versus TNS plus oral placebo, Outcome 4: Number of hospitalisations
7.5
7.5. Analysis
Comparison 7: Inhaled tobramycin (TNS) plus oral azithromycin versus TNS plus oral placebo, Outcome 5: Isolation of other micro‐organisms at any time point post‐baseline
7.6
7.6. Analysis
Comparison 7: Inhaled tobramycin (TNS) plus oral azithromycin versus TNS plus oral placebo, Outcome 6: Adverse events
8.1
8.1. Analysis
Comparison 8: Oral ciprofloxacin and inhaled colistin versus no treatment, Outcome 1: Proportion colonised with P aeruginosa
9.1
9.1. Analysis
Comparison 9: AZLI 14 days plus placebo 14 days versus AZLI 28 days, Outcome 1: Proportion of participants with negative cultures at 28 days
9.2
9.2. Analysis
Comparison 9: AZLI 14 days plus placebo 14 days versus AZLI 28 days, Outcome 2: Adverse Events
10.1
10.1. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 1: Eradication of P aeruginosa from respiratory samples at 3 months and remaining free
10.2
10.2. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 2: FEV1 % predicted
10.3
10.3. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 3: FVC % predicted
10.4
10.4. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 4: FEF25-75
10.5
10.5. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 5: Growth and nutritional status: height‐for‐age z score
10.6
10.6. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 6: Growth and nutritional status: weight‐for‐age z score
10.7
10.7. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 7: Growth and nutritional status: BMI z score (paediatric)
10.8
10.8. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 8: Growth and nutritional status: BMI (kg/m2; adult)
10.9
10.9. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 9: Frequency of exacerbations: number of participants who experienced an exacerbation
10.10
10.10. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 10: Frequency of exacerbations: number of participants admitted to hospital
10.11
10.11. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 11: Isolation of other organisms: number of participants isolating a positive culture during 15‐month study period
10.12
10.12. Analysis
Comparison 10: IV ceftazidime with tobramycin versus oral ciprofloxacin, Outcome 12: Adverse events
See this image and copyright information in PMC

Update of

References

References to studies included in this review

ALPINE2 2017 {published data only}
    1. EUCTR2016-002749-42-GR. Study of aztreonam for inhalation in children with cystic fibrosis and new infection of the airways by pseudomonas aeruginosa bacteria [Randomized, double-blind, phase 3B trial to evaluate the safety and efficacy of 2 treatment regimens of aztreonam 75 mg powder and solvent for nebulizer solution / aztreonam for inhalation solution (AZLI) in pediatric subjects with cystic fibrosis (CF) and new onset respiratory tract pseudomonas aeruginosa (PA) infection/colonization - ALPINE2 (aztreonam lysine for pseudomonas infection eradication 2)]. www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-002749-42-GR (first received 03 October 2017). [CENTRAL: CN-01890414] [CFGD REGISTER: PI302]
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    1. EUCTR2009-016590-15-IT. Evaluation of the efficacy and safety of tobramycin for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years. trialsearch.who.int/?TrialID=EUCTR2009-016590-15-IT (first posted 14 Mar 2012). [CFGD REGISTER: PI290d]
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Gibson 2003 {published data only}
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OPTIMIZE 2018 {published data only}
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    1. Mayer-Hamblett N, Retsch-Bogart G, Kloster M, Accurso F, Rosenfeld M, Albers G, et al. Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial. American Journal of Respiratory and Critical Care Medicine 2018;198(9):1177-87. [CFGD REGISTER: MA31b] - PMC - PubMed
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    1. NCT02054156. Optimizing treatment for early pseudomonas aeruginosa infection in cystic fibrosis [Optimizing treatment for early pseudomonas aeruginosa infection in cystic fibrosis: the OPTIMIZE multicenter, placebo-controlled, double-blind, randomized trial]. clinicaltrials.gov/show/NCT02054156 (first posted 04 February 2014). [CENTRAL: CN-01543461] [CFGD REGISTER: MA31c]
    1. Pittman JE, Skalland MS, Sagel SD, Ramsey BW, Mayer-Hamblett N, Retsch-Bogart GZ. Impact of azithromycin on serum inflammatory markers in children with cystic fibrosis and new Pseudomonas. Journal of Cystic Fibrosis 2022 Mar 05 [Epub ahead of print]. [CFGD REGISTER: MA31g] [DOI: 10.1016/j.jcf.2022.02.015] - DOI - PMC - PubMed
Proesmans 2013 {published data only}
    1. NCT01400750. Comparison of 2 treatment regimens for eradication of p aeruginosa infection in children with cystic fibrosis [Prospective randomized trial comparing oral ciproxin plus inhaled colistin with tobramycin for inhalation for eradication of p aeruginosa infection in children with cystic fibrosis]. clinicaltrials.gov/show/NCT01400750 (first posted 22 July 2011). [CENTRAL: CN-01487718] [CFGD REGISTER: PI208e]
    1. Proesmans M, Boulanger L, Vermeulen F, De Boeck K. Eradication of recent Pseudomonas aeruginosa isolation: TOBI versus colistin/ciprofloxacin. Journal of Cystic Fibrosis 2008;7(S2):S64. [CFGD REGISTER: PI208a] - PubMed
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    1. Proesmans M, Vermeulen F, Boulanger L, Verhaegen J, De Boeck K. Comparison of two treatment regimens for eradication of Pseudomonas aeruginosa infection in children with cystic fibrosis. Journal of Cystic Fibrosis 2013;12(1):29-34. [CFGD REGISTER: PI208d] - PubMed
Ratjen 2010 {published data only}
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Taccetti 2012 {published data only}
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TORPEDO 2020 {published data only}
    1. Cazares A, Figueroa W, Kenna D, Langton-Hewer S, Smyth A, Winstanley C. Comparative genomics study of a set of Pseudomonas aeruginosa isolates from the TORPEDO-CF trial. Journal of Cystic Fibrosis 2019;18(Suppl 1):S1. [ABSTRACT NO.: WS01-2] [CENTRAL: CN-01989497] [CFGD REGISTER: PI299h] [EMBASE: 2001976388]
    1. EUCTR2009-012575-10-SE. Trial of optimal therapy for pseudomonas eradication in cystic fibrosis - TORPEDO-CF. https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2009-012575-10-SE (first received 04 October 2016). [CENTRAL: CN-01798235] [CFGD REGISTER: PI299d]
    1. ISRCTN02734162. Trial of optimal therapy for pseudomonas eradication in cystic fibrosis. trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN02734162 (first registered 22 May 2009). [CENTRAL: CN-01807478] [CFGD REGISTER: PI299f]
    1. Langton Hewer S, Hickey H, Jones A, Blundell M, Smyth AR, on behalf of theTORPEDO-CFcontributors. TORPEDO-CF-completion of recruitment to trial of optimal regimen for eradication of new infection with Pseudomonas aeruginosa. Journal of Cystic Fibrosis 2017;16 Suppl 1:S80. [CENTRAL: CN-01461886] [CFGD REGISTER: PI299a] [EMBASE: 620749438]
    1. Langton Hewer S, Smyth AR, Jones A, Williamson P. Torpedo-CF – trial of optimal therapy for pseudomonas eradication in cystic fibrosis. Pediatric Pulmonology 2018;53 Suppl 2:294. [CENTRAL: CN-01722917] [CFGD REGISTER: PI299b] [EMBASE: 624049385]
Treggiari 2011 {published data only}
    1. Anstead M, Heltshe SL, Khan U, Barbieri JT, Langkamp M, Doring G, et al. Pseudomonas aeruginosa serology and risk for re-isolation in the EPIC trial. Journal of Cystic Fibrosis 2013;12(2):147-53. [CENTRAL: 1089772] [CFGD REGISTER: PI202m] [PMID: ] - PMC - PubMed
    1. Anstead M, Lymp J, Khan U, Barbieri J, Langkamp M, Doring G, et al. Pseudomonas aeruginosa serology predicts response to treatment and re-infection in the EPIC clinical study. Pediatric Pulmonology 2011;46(S34):303. [ABSTRACT NO: 254] [CFGD REGISTER: PI202g]
    1. Anstead M, Saiman L, Mayer-Hamblett N, Lands LC, Kloster M, Goss CH, et al. Pulmonary exacerbations in CF patients with early lung disease. Journal of Cystic Fibrosis 2014;13(1):74-9. [CENTRAL: CN-00961723] [CFGD REGISTER: PI202l] [EMBASE: 2013796396] [PMID: ] - PubMed
    1. Cogen JD, Onchiri FM, Hamblett NM, Gibson RL, Morgan WJ, Rosenfeld M. Association of intensity of antipseudomonal antibiotic therapy with risk of treatment-emergent organisms in children with cystic fibrosis and newly acquired Pseudomonas aeruginosa. Clinical Infectious Diseases 2021;73(6):987-93. [CFGD REGISTER: PI202s] - PMC - PubMed
    1. Hamblett NM, Retsch-Bogart GZ, Treggiari M, Kronmal RA, Khan U, Williams J, et al. Safety and efficacy of anti-pseudomonal therapy for early eradication of Pseudomonas aeruginosa: the EPIC study. Pediatric Pulmonology 2009;44(S32):183. [CFGD CF REGISTER: PI202b] [MEDLINE: ]
Valerius 1991 {published data only}
    1. Valerius NH, Koch C, Høiby N. Prevention of chronic Pseudomonas aeruginosa colonisation in cystic fibrosis by early treatment. Lancet 1991;338(8769):725-6. [CFGD REGISTER: PI70b] - PubMed
    1. Valerius NH, Koch C, Høiby N. Prevention of chronic colonization with Pseudomonas aeruginosa in patients with CF by early treatment with ciprofloxacin and colistin aerosol inhalations. Pediatric Pulmonology 1990;9(Suppl 5):248. [CFGD REGISTER: PI70a]
Wiesemann 1998 {published data only}
    1. Ratjen F, Steinkamp G, Döring G, Bauernfeind A, Wiesemann HG, Von Der Hardt H. Prevention of chronic pseudomonas aeruginosa infection by early inhalation therapy with tobramycin. Pediatric Pulmonology 1994;Suppl 10:250. [CFGD REGISTER: PI101a]
    1. Wiesemann HG, Steinkamp G, Ratjen F, Bauernfeind A, Przyklenk B, Döring G, et al. Placebo-controlled, double-blind, randomised study of aerosolised tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis. Pediatric Pulmonology 1998;25(2):88-92. [CFGD REGISTER: PI101b] - PubMed

References to studies excluded from this review

Alothman 2002 {published data only}
    1. Alothman GA, Alsaadi MM, Ho BL, Ho SL, Dupuis A, Corey M, et al. Evaluation of bronchial constriction in children with cystic fibrosis after inhaling two different preparations of tobramycin. Chest 2002;122(3):930-4. [CENTRAL: 398028] [CFGD REGISTER: PI157b] [PMID: ] - PubMed
    1. Alothman GA, Coates AL, Corey M, Dupuis A, Ho SL, Ho BL, et al. In cystic fibrosis (CF) patients, does the inhalation of an intravenous tobramycin preparation result in more bronchospasm than a preservative free tobramycin preparation? Pediatric Pulmonology 2000;Suppl 20:298-9. [CFGD REGISTER: PI157a]
Alothman 2005 {published data only}
    1. Alothman GA, Ho B, Alsaadi MM, Ho SL, O'Drowsky L, Louca E, et al. Bronchial constriction and inhaled colistin in cystic fibrosis. Chest 2005;127(2):522-9. [CENTRAL: 502709] [CFGD REGISTER: PI190] [PMID: ] - PubMed
Ballman 1998 {published data only}
    1. Ballman M, Rabsch P, Hardt H. Long term follow up of changes in FEV1 and treatment intensity during Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. Thorax 1998;53(9):732-7. - PMC - PubMed
Brett 1992 {published data only}
    1. Brett MM, Simmonds EJ, Ghonheim ATM, Littlewood JM. The value of serum IgG titres against Pseudomonas aeruginosa in the management of early infection in cystic fibrosis. Archives of Disease in Childhood 1992;67(9):1086-8. [CFGD REGISTER: PI73] - PMC - PubMed
Bustamante 2014 {published data only}
    1. Bustamante AE, Mercado-Longoria R, Tijerina-Menchaca R, Mas-Trevino M, Torres-Rodriguez JN. Impact of eradication of Pseudomonas aeruginosa on survival in Mexican patients with cystic fibrosis. Revista de Investigacion Clinica 2014;66(4):307-13. [CENTRAL: CN-01050728] [CFGD REGISTER: PI303] [PMID: ] - PubMed
Church 1997 {published data only}
    1. Church DA, Kanga JF, Kuhn RJ, Rubio TT, Spohn WA, Stevens JC, et al. Sequential ciprofloxacin therapy in pediatric cystic fibrosis: comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations. The Cystic Fibrosis Study Group. Pediatric Infectious Disease Journal 1997;16(1):97-105. [CENTRAL: 135891] [CFGD REGISTER: PI115] [PMID: ] - PubMed
Clancy 2013 {published data only}
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818-25 Online Supplementary Data. [CFGD REGISTER: PI207f // PI222d] - PMC - PubMed
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818-25. [CENTRAL: 876398] [CFGD REGISTER: PI207e // PI222c] [PMID: ] - PMC - PubMed
    1. Clancy JP, Minic P, Dupont L, Goss CH, Quittner AL, Lymp JF, et al. Full analysis of data from two phase II blinded & placebo-controlled studies of nebulized liposomal amikacin for inhalation (Arikace) in the treatment of CF patients with pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:299. [ABSTRACT NO: 227] [CENTRAL: 848916] [CFGD REGISTER: PI207d // PI222b]
    1. Dupont L, Minic P, Fustic S, Mazurek H, Solyom E, Feketova A, et al. A randomised placebo-controlled study of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. Journal of Cystic Fibrosis 2008;7 Suppl 2:S26. [CENTRAL: 790820] [CFGD REGISTER: PI207a]
    1. Dupont LJ, Clancy JP, Minic P, Goss CH, Fustic S, Mazurek Hetal. Evaluation of two phase II blinded and placebo-controlled studies of nebulized liposomal amikacin (arikace") in the treatment of cystic fibrosis patients with pseudomonas aeruginosa lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A1836. [CENTRAL: CN-00758757] [CFGD REGISTER: PI222e // PI207g]
Coates 2011 {published data only}
    1. Coates AL, Denk O, Leung K, Ribeiro N, Chan J, Green M, et al. Higher tobramycin concentration and vibrating mesh technology can shorten antibiotic treatment time in cystic fibrosis. Pediatric Pulmonology 2011;46(4):401-8. [CENTRAL: 786190] [CFGD REGISTER: PI241b] - PubMed
    1. Denk O, Caotes AL, Keller M, Leung K, Green M, Chan J, et al. Lung delivery of a new tobramycin nebuliser solution (150mg/1.5ml) by an investigational eFlow® nebuliser is equivalent to TOBI® but in a fraction of time. Journal of Cystic Fibrosis 2009;8 Suppl 2:S66. [ABSTRACT NO: 264] [CENTRAL: 794467] [CFGD REGISTER: PI241c]
    1. Keller M, Coates AL, Griese M, Denk O, Schierholz J, Knoch M. In-vivo data support equivalent therapeutic efficacy of a new tobramycin inhalation solution (150mg/1.5ml) administered by the eFlow® electronic nebuliser compared to TOBI® in the PARI LC PLUS®. Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [ABSTRACT NO: 84] [CENTRAL: 794286] [CFGD REGISTER: PI241a]
Di Cicco 2014 {published data only}
    1. Claut L, DiCicco M, Cariani L, Defilippi G, Costantini D, Colombo C. Tobramycin and hyaluronic acid nasal solution: beyond antimicrobial effect. Pediatric Pulmonology 2011;46 Suppl 34:322. [ABSTRACT NO.: 304] [CFGD REGISTER: CO52a]
    1. Di Cicco M, Alicandro G, Claut L, Cariani L, Luca N, Defilippi G, et al. Efficacy and tolerability of a new nasal spray formulation containing hyaluronate and tobramycin in cystic fibrosis patients with bacterial rhinosinusitis. Journal of Cystic Fibrosis 2014;13(4):455-60. [CFGD REGISTER: CO52b] - PubMed
    1. EUCTR2007-003628-39-IT. Pilot study to evaluate the local tolerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2007-003628-39-IT (date of registration 08 Apr 2008). [CFGD REGISTER: CO52c]
Elborn 2015 {published data only}
    1. Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026)treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Journal of Cystic Fibrosis 2016;15(5):634-40. [CFGD REGISTER: PI262d] - PubMed
    1. Elborn JS, Flume PA, Loutit J, Cohen F. Prolonged improvement in lung function and quality of life in cystic fibrosis: a 24-week extension study of levofloxacin nebulization solution (APT-1026) versus tobramycin nebulization solution in stable CF patients with chronic pseudomonas aeruginosa infection. Journal of Cystic Fibrosis 2014;13 Suppl 2:S16. [ABSTRACT NO: WS7.5] [CENTRAL: 1000055] [CFGD REGISTER: PI262b]
    1. Elborn JS, Geller D, Conrad D, Aaron S, Smyth AR, Fischer R, et al. Phase 3 trial of inhaled levofloxacin (Aeruquinâ™, MP-376, APT-1026) vs. tobramycin inhalation solution (TIS) in intensively treated CF patients over 6 months. Journal of Cystic Fibrosis 2013;12 Suppl 1:S35. [ABSTRACT NO: WS17.6] [CENTRAL: 867323] [CFGD REGISTER: PI262a]
    1. Elborn JS, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, et al. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2015;14(4):507-14. [CENTRAL: 1038490] [CFGD REGISTER: PI262c] [JID:: 101128966] [PMID: ] - PubMed
    1. Elborn JS, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, et al. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2015;14(4):507-14. Online supplementary material. [CENTRAL: 1038490] [CFGD REGISTER: PI262e] [JID:: 101128966] [PMID: ] - PubMed
Flume 2015a {published data only}
    1. Fischer R, Flume PA, Van Devanter DR, Polu K, Pecoraro M, Bhatt N, et al. Pulmonary exacerbations and changes in lung function in CF adults with P. aeruginosa treated with inhaled levofloxacin (Quinsair®) or tobramycin. Journal of Cystic Fibrosis 2016;51 Suppl 45:359. [ABSTRACT NO: 436] [CENTRAL: 1262259] [CFGD REGISTER: PI283d]
    1. Flume P, Elborn JS, Polu K, Llorens L, Pecoraro ML, Bhatt N, et al. History of pulmonary exacerbations (PEx) as a predictor of response to nebulized levofloxacin compared with nebulized tobramycin. Journal of Cystic Fibrosis 2016;2015 Suppl 1:S61. [ABSTRACT NO: 38] [CENTRAL: 1171477] [CFGD REGISTER: PI283e]
    1. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis 2015;14 Suppl 1:S87. [ABSTRACT NO: 117] [CENTRAL: 1077213] [CFGD REGISTER: PI240f // PI283c // PI284c]
    1. Flume P. Trial of aeroquin versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients. clinicaltrials.gov/ct2/show/NCT01270347 (first posted 05 January 2011). [CENTRAL: 1012530] [CFGD REGISTER: PI283a] [5500131000000187]
    1. Schwarz C, Spinola M, Flume PA, Elborn JS. Potential taste disturbance is largely mild and diminishes with continuing treatment in cystic fibrosis patients treated with levofloxacin inhaled solution. Journal of Cystic Fibrosis 2018;17 Suppl 3:S81-2. [CENTRAL: CN-01608984] [CFGD REGISTER: PI283f] [EMBASE: 622930778]
Flume 2015b {published data only}
    1. Flume PA, Clancy JP, Retsch-Bogart GZ, Tullis DE, Bresnik M, Derchak PA, et al. Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis. Journal of Cystic Fibrosis 2016;15(6):809-15. [CENTRAL: CN-01291623] [CFGD REGISTER: PI288b] [EMBASE: 610620040] [PMID: ] - PubMed
    1. Flume PA, Clancy JP, Retsch-Bogart GZ, Tullis E, Bresnik M, Derchak PA, et al. Aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) continuous alternating therapy (CAT) for cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (PA) infection: a randomized, double-blind, placebo-controlled trial. Pediatric Pulmonology 2015;50 Suppl 41:352. [ABSTRACT NO: 428] [CENTRAL: 1092171] [CFGD REGISTER: PI288a]
Flume 2016 {published data only}
    1. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis 2015;14 Suppl 1:S87. [ABSTRACT NO: 117] [CENTRAL: 1077213] [CFGD REGISTER: PI240f // PI283c // PI284c]
    1. Flume P. MP-376 (Aeroquin™, Levofloxacin for Inhalation) in patients with cystic fibrosis [A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) in stable cystic fibrosis patients]. clinicaltrials.gov/ct2/show/NCT01180634 (first posted 12 August 2010). [CENTRAL: 1012532] [CFGD REGISTER: PI284a] [NCT01180634] - PubMed
    1. Flume PA, VanDevanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, et al. A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2016;15(4):495-502. [CFGD REGISTER: PI284d] - PubMed
    1. Flume PA, VanDevanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, et al. A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2016;15(4):495-502. Online supplement. [CFGD REGISTER: PI284e] - PubMed
    1. Van Devanter D, Flume PA, Fleming R, Elborn J. How often is pulmonary exacerbation defined by ≥4 Fuchs criteria associated with antibiotic treatment? Pediatric Pulmonlogy 2014;49 Suppl 38:356. [ABSTRACT NO: 388] [CFGD REGISTER: PI283b // PI284b]
Frederiksen 1997 {published data only}
    1. Frederiksen B, Koch C, Høiby N. Antibiotic treatment of initial colonisation with Pseudomonas aeruginosa postpones chronic infection and prevents deterioration of pulmonary function in cystic fibrosis. Pediatric Pulmonology 1997;23(5):330-5. - PubMed
Frost 2021 {published data only}
    1. Frost F, Fothergill J, Winstanley C, Nazareth D, Walshaw MJ. Inhaled aztreonam lysine recovers lung function and improves quality of life in acute pulmonary exacerbations of cystic fibrosis. Thorax 2019;74:A13-4. [CFGD REGISTER: PI310b]
    1. Frost F, Fothergill J, Winstanley C, Walshaw M, Nazareth D. Aztreonam lysine inhalation solution recovers lung function and improves quality of life in treatment of acute pulmonary exacerbation of cystic fibrosis. Pediatric Pulmonology 2019;54 Suppl 2:430. [CFGD REGISTER: PI310c]
    1. Frost F, Fothergill J, Winstanley C, Walshaw M, Nazareth D. Aztreonam lysine recovers lung function and improves quality of life in the treatment of acute exacerbations of cystic fibrosis: results from an open-label randomised crossover study (AZTEC-CF). Journal of Cystic Fibrosis 2020;19 Suppl:S98. [CFGD REGISTER: PI310e] - PubMed
    1. Frost F, Nazareth D, Walshaw M, Young G, Winstanley C, Fothergill J. Inhaled and intravenous treatment strategies exert different effects on the lung microbiome during acute pulmonary exacerbations of cystic fibrosis: results from the AZTEC-CF study. Journal of Cystic Fibrosis 2020;19 Suppl:S80. [CFGD REGISTER: PI310f]
    1. Frost F, Nazareth D, Walshaw M. Aztec-CF study: aztreonam lysine for inhalation in the treatment of pulmonary exacerbations of cystic fibrosis. Pediatric Pulmonology 2018;53(S2):330. [CFGD REGISTER: PI310a]
Geller 2007 {published data only}
    1. Geller DE, Howenstine M, Conrad C, Smith J, Mulye S, Shrewsbury SB. A phase 1 study to assess the tolerability of a novel tobramycin powder for inhalation (TPI) formulation in cystic fibrosis subjects. Pediatric Pulmonology 2004;38(Suppl 27):250. [CENTRAL: 507896] [CFGD REGISTER: PI187a]
    1. Geller DE, Konstan MW, Smith J, Noonberg SB, Conrad C. Novel tobramycin inhalation powder in cystic fibrosis subjects: Pharmacokinetics and safety. Pediatric Pulmonology 2007;42(4):307-13. [CENTRAL: 587235] [CFGD REGISTER: PI187c] [PMID: ] - PubMed
    1. Rodriguez CA, Shrewsbury SB, Potter SN, Nardella P, Geller DE. Single dose pharmacokinetics of tobramycin after administration of a novel dry powder formulation (TPI) in subjects with cystic fibrosis (cf). Pediatric Pulmonology 2004;38 Suppl 27:250. [CENTRAL: 526254] [CFGD REGISTER: PI187b]
Geller 2011 {published data only}
    1. Conrad D, Flume P, Sindel L, Andrews S, Morgan L, Loutit J, et al. Phase 2b study of inhaled MP-376 (Aeroquin, levofloxacin inhalation solution) in stable cystic fibrosis (CF) patients with chronic Pseudomonas Aeruginosa (PA) lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A2239. [CENTRAL: 1031676] [CFGD REGISTER: PI240g] [EMBASE: 70839804]
    1. Flume P, Geller DE, Sindel L, Staab D, Fischer R, Riethmuller J, et al. Effects of inhaled MP-376 (aeroquin, levofloxacin inhalation solution) on lung function in stable cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (PA) lung infection. Journal of Cystic Fibrosis 2010;9 Suppl 1:S23. [ABSTRACT NO: 86] [CENTRAL: 774683] [CFGD REGISTER: PI240a]
    1. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis 2015;14 Suppl 1:S87. [ABSTRACT NO: 117] [CENTRAL: 1077213] [CFGD REGISTER: PI240f // PI283c // PI284c]
    1. Flume PA, Geller DE, Loutit JS, Dudly MN, Conrad D, Mpex 204Sgroup. Effects of inhaled MP-376 (Aeroquinâ„¢ levofloxacin inhalation solution) on cystic fibrosis patients with both Staphylococcus aureus (SA) and Pseudomonas aeruginosa (PA) lung infection. Journal of Cystic Fibrosis 2011;10 Suppl 1:S22. [ABSTRACT NO: 87] [CENTRAL: 849020] [CFGD REGISTER: PI240b]
    1. Geller DE, Flume PA, Staab D, Fischer R, Loutit JS, Conrad DJ. Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa. American Journal of Respiratory and Critical Care Medicine 2011;183(11):1510-1516. Online Supplemental Methods. [CENTRAL: 1073292] [CFGD REGISTER: PI240e] - PubMed
Gibson 2007 {published data only}
    1. Gibson RL, Emerson J, Mayer-Hamblett N, Burns JL, McNamara S, Accurso FJ, et al. Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis. Pediatric Pulmonology 2007;42(7):610-23. - PubMed
Goss 2009 {published data only}
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818-25. [CENTRAL: 876398] [CFGD REGISTER: PI222c // PI207e] [PMID: ] - PMC - PubMed
    1. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818-25. Online Supplementary Data. [CFGD REGISTER: PI222d // PI207f] - PMC - PubMed
    1. Clancy JP, Minic P, Dupont L, Goss CH, Quittner AL, Lymp JF, et al. Full analysis of data from two phase II blinded & placebo-controlled studies of nebulized liposomal amikacin for inhalation (Arikace) in the treatment of CF patients with Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:299. [ABSTRACT NO: 227] [CFGD REGISTER: PI222b //PI207d]
    1. Dupont LJ, Clancy JP, Minic P, Goss CH, Fustic S, Mazurek Hetal. Evaluation of two phase II blinded and placebo-controlled studies of nebulized liposomal amikacin (arikace") in the treatment of cystic fibrosis patients with pseudomonas aeruginosa lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A1836. [CENTRAL: CN-00758757] [CFGD REGISTER: PI222e // PI207g]
    1. Goss CH, Clancy JP, Nick JA, Billings J, Rubenstein RC, Young KR, et al. A phase 2 blinded and placebo-controlled study of nebulized liposomal amikacin (arikace) in the treatment of CF patients with Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2009;44(S32):295. [CFGD CF REGISTER: PI222a]
Griese 2002 {published data only}
    1. Griese M, Mueller I, Reinhardt D. Eradication of initial Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. European Journal of Medical Research 2002;7(2):79-80. - PubMed
Hansen 2015 {published data only}
    1. EUCTR2006-003275-12-DK. Scandinavian Cystic Fibrosis Azithromycin Study Supplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study. trialsearch.who.int/?TrialID=EUCTR2006-003275-12-DK (date of registration 17 Apr 2007). [CFGD REGISTER: PI337b]
    1. Hansen CR, Pressler T, Olesen HV, Storosten O, Lerum B, Norskov-Lauritsen N, et al. Azithromycin in combination with inhaled colimycin and oral ciprofloxacin used for intermittent pseudomonas aeruginosa colonization in cystic fibrosis patients: results from a Scandinavian study. Pediatric Pulmonology 2015;50 Suppl 41:318. [ABSTRACT NO.: 336] [CENTRAL: CN-01163938] [CFGD REGISTER: MA30] [EMBASE: 72081615]
    1. NCT00411736. Scandinavian cystic fibrosis azithromycin study. https://clinicaltrials.gov/show/NCT00411736 (first posted 15 Dec 2006). [CFGD REGISTER: PI337a]
Heinzl 2002 {published data only}
    1. Heinzl B, Eber E, Oberwaldner B, Haas G, Zach M. Effects of inhaled gentamicin prophylaxis on acquisition of Pseudomonas aeruginosa in children with cystic fibrosis: a pilot study. Pediatric Pulmonology 2002;33(1):32-7. - PubMed
Herrmann 2017 {published data only}
    1. Herrmann G, Freitag E, Kiefer L, Bender V, Adams C, Graepler-Mainka U, et al. Combined dry powder tobramycin and nebulized colistin versus colistin inhalation in CF patients - a randomised, open label phase III clinical study. Journal of Cystic Fibrosis 2017;16 Suppl 1:S54. [ABSTRACT NO.: EPS7.8] [CENTRAL: CN-01767442] [CFGD REGISTER: PI294] [EMBASE: 620749566]
Kenny 2009 {published data only}
    1. Kenny S, Hall V, Goldsmith C, Moore J, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with CF. Journal of Cystic Fibrosis 2009;8 Suppl 2:S39. [ABSTRACT NO: 158] [MEDLINE: ]
    1. Kenny SL, Shaw TD, Downey DG, Moore JE, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with cystic fibrosis. BMJ Open Respiratory Research 2014;1:e000021. - PMC - PubMed
Konstan 2010 {published data only}
    1. Konstan MW, Geller DE, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder is effective and safe in the treatment of chronic pulmonary Pseudomonas aeruginosa (Pa) infection in patients with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2009;179. [ABSTRACT NO: A1186] [CENTRAL: 744126] [CFGD REGISTER: PI227a] [DOI: 10.1164/ajrccm-conference.2009.179.1_MeetingAbstracts.A1186] - DOI
    1. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Effective treatment of chronic Pseudomonas aeruginosa (Pa) infection with tobramycin inhalation powder in CF patients. Journal of Cystic Fibrosis 2009;8 Suppl 2:S27. [ABSTRACT NO: 105] [CENTRAL: 744127] [CFGD REGISTER: PI227b]
    1. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: The EVOLVE trial. Pediatric Pulmonology 2010;46:230-8. [CENTRAL: 867122] [CFGD REGISTER: PI227e] [PMID: ] - PMC - PubMed
    1. McColley S, Rietschel E, Brockhaus F, Angyalosi G, Higgins M. Safety of inhaled tobramycin in patients with cystic fibrosis. Pediatric Pulmonology 2011;46 Suppl 34:344. [ABSTRACT NO: 365] [CENTRAL: 848919] [CFGD REGISTER: PI227d // PI239h]
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Konstan 2011 {published data only}
    1. Chiron R, Geller DE, Angyalosi G, Debonnett L, Yadao A, Bader G, et al. Tobramycin powder for inhalation is effective in advanced stage CF lung disease: the EAGER trial. Journal of Cystic Fibrosis 2014;13 Suppl 2:S57. [ABSTRACT NO: 42] [CENTRAL: 996576] [CFGD REGISTER: PI239k]
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    1. Geller DE, Flume PA, Brockhaus F, Zhang J, Angyalosi G, He E, et al. Treatment convenience and satisfaction of tobramycin inhalation powder (TIP) versus TOBI in cystic fibrosis (CF) patients. Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [ABSTRACT NO: 82] [CENTRAL: 776791] [CFGD REGISTER: PI239b]
    1. Geller DE, Flume PA, Konstan M, Angyalosi G, Higgins M. Microbiological and clinical response to tobramycin inhalation powder (TIPâ„¢) in cystic fibrosis patients with chronic Pseudomonas aeruginosa (Pa) infection [abstract]. Journal of Cystic Fibrosis 2011;10 Suppl 1:S21. [ABSTRACT NO: 82] [CENTRAL: 848918] [CFGD REGISTER: PI239g]
    1. Geller DE, Nasr SZ, Piggott S, He E, Angyalosi G, Higgins M. Tobramycin inhalation powder in cystic fibrosis patients: response by age group. Respiratory Care 2014;59(3):388-98. [CFGD REGISTER: PI239l] [PMID: ] - PubMed
Konstan 2015 {published data only}
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Latzin 2008 {published data only}
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Lenoir 2007 {published data only}
    1. Lenoir G, Antypkin YG, Miano A, Moretti P, Zanda M, Varoli G, et al. Efficacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Paediatric Drugs 2007;9 Suppl:11-20. [CFGD REGISTER: PI196c] - PubMed
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Littlewood 1985 {published data only}
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Mainz 2014 {published data only}
    1. EUCTR2008-000164-17-DE. Nasale inhalation von tobramycin mit dem pari sinus-vernebler bei patienten mit mukoviszidose und pseudomonasnachweis IM nasen-nasennebenhohlenbereich. Nasal inhalation of tobramycin by the pari sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot. trialsearch.who.int/?TrialID=EUCTR2008-000164-17-DE (first posted 26 May 2008). [CFGD REGISTER: PI248d]
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Mazurek 2012 {published data only}
    1. Mazurek H, Chiron R, Pelikan L, Geidel C, Bolbas K, Antipkin Y, et al. Comparison of two inhaled tobramycin solutions in cystic fibrosis patients with chronic pseudomonas aeruginosa infection: results in different age subgroups. Journal of Cystic Fibrosis 2011;10 Suppl 1:S28. [ABSTRACT NO: 111] [CENTRAL: 848929] [CFGD REGISTER: PI249b]
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Oermann 2009 {published data only}
    1. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson R, McKevitt M, Montgomery B. Antibiotic susceptibility in Pseudomonas Aeruginosa (PA) isolates following exposure to aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis. Pediatric Pulmonology 2009;44(S32):309. [ABSTRACT NO: 278] [CFGD CF REGISTER: PI220a]
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Prayle 2013 {published data only}
    1. NCT01207245. Circadian rhythm in tobramycin elimination in cystic fibrosis. clinicaltrials.gov/show/NCT01207245 (first posted 22 Sep 2010). [CFGD REGISTER: CO55c]
    1. Prayle A, Jain K, Watson A, Smyth AR. Are morning doses of intravenous tobramycin less nephrotoxic than evening? Evidence from urinary biomarkers in the critic study. Pediatric Pulmonology 2013;48 Suppl 36:299. [ABSTRACT NO: 261] [CENTRAL: 980338] [CFGD REGISTER: CO55a]
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Retsch‐Bogart 2009 {published data only}
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Rietschel 2009 {published data only}
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Schelstraete 2010 {published data only}
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Schuster 2013 {published data only}
    1. EUCTR2004-003675-36-BE. A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection. trialsearch.who.int/?TrialID=EUCTR2004-003675-36-BE (date of registration 13 Oct 2005). [CFGD REGISTER: PI214h]
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Stass 2013 {published data only}
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Stockmann 2015 {published data only}
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    1. Cheney J, Wainwright C, ACFBAL SG. Trials, tribulations and triumphs of a cystic fibrosis study - a behind the scenes look at the workings of an international multi-centre study. Journal of Cystic Fibrosis 2010;9 Suppl 1:S118. [ABSTRACT NO: 452] [CENTRAL: 790042] [CFGD REGISTER: PE167g]
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    1. Moodie M, Lal A, Vidmar S, Armstrong DS, Byrnes CA, Carlin JB, et al. Costs of bronchoalveolar lavage-directed therapy in the first 5 years of life for children with cystic fibrosis. Journal of Pediatrics 2014;165(3):564-9. [CFGD REGISTER: PE167j] [JID:: 0375410] [PMID: ] [SI:: ANZCTR/ACTRN12605000665639] - PubMed
Wainwright 2011b {published data only}
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References to studies awaiting assessment

Noah 2010 {published data only}
    1. NCT00823238. Comparison of antibiotics for pseudomonas in early CF. clinicaltrials.gov/show/NCT00823238 (first posted 15 Jan 2008). [CFGD REGISTER: PI205c]
    1. Noah T, Ivins S, Abode K, Harris W, Henry M, Leigh M. Comparison of antibiotics for early pseudomonas infection in CF: interim data analysis. Pediatric Pulmonology 2007;42(S30):332. [CFGD REGISTER: PI205a]
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References to ongoing studies

EUCTR2007‐003868‐22‐FR {published data only}
    1. EUCTR2007-003868-22-FR. Assesment of efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients receiving antibiotherapy for 28 days for pseudomonas aeruginosa primo colonisation. - nebcinal 01-07. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2007-003868-22-FR (date of registration 20 December 2007). [CENTRAL: CN-01805067] [CFGD REGISTER: PI300]
EUCTR2011‐006171‐19‐IT {published data only}
    1. EUCTR2011-006171-19-IT. Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old [Randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old]. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2011-006171-19-IT (date of registration 13 January 2012). [CENTRAL: CN-01814460] [CFGD REGISTER: PI301]
EUCTR2015‐003881‐96‐IT {published data only}
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