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Meta-Analysis
. 2019 Dec 17;12(12):CD012300.
doi: 10.1002/14651858.CD012300.pub2.

Treatments for preventing recurrence of infection with Pseudomonas aeruginosa in people with cystic fibrosis

Sally Palser  1 , Sherie Smith  2 , Edward F Nash  3 , Arnav Agarwal  4 , Alan R Smyth  1
Affiliations
Meta-Analysis

Treatments for preventing recurrence of infection with Pseudomonas aeruginosa in people with cystic fibrosis

Sally Palser et al. Cochrane Database Syst Rev. .

Abstract

Background: Chronic infection with Pseudomonas aeruginosa (PA) in cystic fibrosis (CF) is a source of much morbidity and mortality. Eradication of early PA infection is possible, but can recur in many individuals. We sought to examine strategies to delay the time to PA recurrence in people with CF.

Objectives: To establish whether secondary prevention strategies, using antibiotics or other therapies, increase the chances of people with CF remaining free from PA infection following successful eradication therapy.

Search methods: We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched ongoing trials registries and the reference lists of relevant articles and reviews. Date of last search: 21 August 2019.

Selection criteria: Randomised controlled trials (and quasi-randomised trials where the risk of bias was low) comparing any treatment modality aimed at preventing recurrence of PA infection with placebo, standard therapy or any other treatment modality in people with CF who have undergone successful eradication of PA.

Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias. Quality of the evidence was assessed using GRADE. Conflicts were resolved by discussion and the opinion of a third review author was sought where necessary. Only a subset of participants in the included trial were eligible, therefore individual participant data were requested and obtained from the trial investigators.

Main results: We included one trial (n = 306) in the review; however, only 253 participants had undergone successful eradication of PA, so fulfilling the inclusion criteria for our review. Information presented relates only to the included subset of participants. The trial recruited children aged one to 12 years (mean (standard deviation (SD)) age of 5.8 (3.5) years), 129 participants (51.0%) were female and the median follow-up was 494 days. We compared cycled therapy with tobramycin inhalation solution (TIS), in which participants underwent 28 days of TIS every three months, with culture-based therapy, in which participants were only prescribed medication when a quarterly sputum sample was positive for PA. Reasons for downgrading the quality of the evidence included applicability (only included children), incomplete outcome data and a small number of participants. The time to next isolation of PA was probably shorter with cycled TIS therapy than with culture-based therapy, hazard ratio (HR) 2.04 days (95% confidence interval (CI) 1.28 to 3.26) (moderate-quality evidence). This is in contrast to the main publication of the only included trial, which examined rate of PA positivity rather than time to PA infection and included participants not eligible for inclusion in this review. At the end of the trial, there was no difference between the cycled and culture-based groups in the change from baseline in forced expiratory volume in one second (FEV1) L, mean difference (MD) 0.0 L (95% CI -0.09 to 0.09) or in FEV1 % predicted, MD 0.70% (95% CI -4.33 to 5.73) (both very low-quality evidence). There was no difference in the change from baseline for FVC between the groups. There was also no difference in the frequency of pulmonary exacerbations between groups, MD -0.18 (95% CI -0.51 to 0.14) (moderate-quality evidence). Similarly, there was no difference between groups in the risk of participants developing novel resistant bacteria, RR 1.00 (95% CI 0.67 to 1.5) (moderate-quality evidence). There were more severe adverse events in the cycled group, but the type of treatment probably makes little or no difference to the results, RR 0.65 (95% CI 0.39 to 1.11) (moderate-quality evidence). There was no difference between groups in the change in weight or height from baseline or in rates of adherence to tobramycin or all trial medicines. The included trial did not assess changes in quality of life, the time to chronic infection with PA or the cost-effectiveness of treatment.

Authors' conclusions: Cycled TIS therapy may be beneficial in prolonging the time to recurrence of PA after successful eradication, but further trials are required, specifically addressing this question and in both adults and children.

PubMed Disclaimer

Conflict of interest statement

Dr Sally Palser declares that her salary is funded by a Research for Patient Benefit grant from the National Institute of Health Research (NIHR), PB‐PG‐0213‐30055.

Dr Edward Nash declares no known potential conflict of interest.

Dr Arnav Agarwal declares no known potential conflict of interest.

Sherie Smith declares no known potential conflict of interest.

Prof Alan Smyth declares relevant activities of consultancy and an Investigator Initiated Award (independent research grant) from Vertex Pharma. He has given lectures at symposia sponsored by Novartis and TEVA. In addition, Prof Smyth has a patent ALKYL QUINOLONES AS BIOMARKERS OF PSEUDOMONAS AERUGINOSA INFECTION AND USES THEREOF issued.

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 Cycled versus culture‐based therapy, Outcome 1 Time to next isolation of PA in participants PA negative at visit 2.
1.2
1.2. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 2 Time to next isolation of PA in participants PA negative at visit 3.
1.3
1.3. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 3 FEV1 (L): absolute change from baseline.
1.4
1.4. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 4 FEV1 (L): relative change in from baseline.
1.5
1.5. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 5 FEV1 % predicted: absolute change from baseline (% predicted).
1.6
1.6. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 6 FEV1 % predicted: relative change from baseline (% predicted).
1.7
1.7. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 7 FVC: absolute change from baseline (L).
1.8
1.8. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 8 FVC: relative change from baseline (L).
1.9
1.9. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 9 Time to next exacerbation.
1.10
1.10. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 10 Number of participants with a pulmonary exacerbation.
1.11
1.11. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 11 Frequency of pulmonary exacerbations (at end of trial).
1.12
1.12. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 12 Weight (kg): absolute change from baseline.
1.13
1.13. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 13 Weight percentile: absolute change from baseline.
1.14
1.14. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 14 Height (cm): absolute change from baseline.
1.15
1.15. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 15 Height percentile: absolute change from baseline.
1.16
1.16. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 16 Adherence: number not returning trial medication.
1.17
1.17. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 17 Adherence: number not returning tobramycin.
1.18
1.18. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 18 Number of severe adverse events.
1.19
1.19. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 19 Isolation of newly resistant PA.
1.20
1.20. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 20 Isolation of newly mucoid PA.
1.21
1.21. Analysis
Comparison 1 Cycled versus culture‐based therapy, Outcome 21 Isolation of novel resistant gram negative organisms.
See this image and copyright information in PMC

Update of

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Taccetti 2012 {published data only}
    1. Cariani L, Defilippi G, Costantini D, Claut L, Clarizia G, D'accico M, et al. Semi‐automated rep‐pcr genotyping of pseudomonas aeruginosa in Italian CF patients in eradication therapy. Pediatric Pulmonology 2010;45(Suppl 33):348. [CFGD Register: PI230c]
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    1. EUCTR2008‐006502‐42‐IT. Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols ‐ #FFC17/2007. www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2008‐006502‐42‐IT (first posted 07 April 2010). [CENTRAL: CN‐01871008; CFGD Register: PI230j; CRS: 10770780]
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    1. Taccetti G, Bianchini E, Zavataro L, Campana S, Defilippi G, Ravenni N, et al. Pseudomonas aeruginosa microbiological status and emergence of other pathogens after early eradication treatment in cystic fibrosis: a post‐trial follow‐up. Pediatric Pulmonology 2011;46 Suppl 34:317. [Abstract no.: 292; CFGD Register: PI230e]
TORPEDO Trial {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; CRS: 12180811; EMBASE: 2001976388]
    1. EUCTR2009‐012575‐10‐SE. Trial of optimal therapy for pseudomonas eradication in cystic fibrosis ‐ TORPEDO‐CF. www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2009‐012575‐10‐SE 2016. [CENTRAL: CN‐01798235; CFGD Register: PI299d; CRS: 10698253]
    1. ISRCTN02734162. Trial of optimal therapy for pseudomonas eradication in cystic fibrosis. www.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN02734162 (first received 22 May 2009). [CENTRAL: CN‐01807478; CFGD Register: PI299f; CRS: 10707427]
    1. Langton Hewer S. TORPEDO‐CF. www.controlled‐trials.com/ISRCTN02734162/torpedo‐cf (first received 10 October 2011). [CFGD Register: PI299c]
    1. Langton Hewer S, Hickey H, Jones A, Blundell M, Smyth AR, on behalf of the TORPEDO‐CF contributors. 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. [CFGD Register: PI299a]
Valerius 1991 {published data only}
    1. Valerius NH, Koch C, Hoiby N. Prevention of chronic Pseudomonas aeruginosa colonisation in cystic fibrosis by early treatment. Lancet 1991;338(8769):725‐6. [CENTRAL: 78099; CFGD Register: PI70b; CRS: 5500100000000484; PUBMED: 1679870] - PubMed
    1. Valerius NH, Koch C, Hoiby 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. [Abstract no.: 219; CENTRAL: 291624; CFGD Register: PI70a; CRS: 5500100000001626]
Wiesemann 1998 {published data only}
    1. Ratjen F, Steinkamp G, Doring G, Bauernfeind A, Wiesemann HG, Hardt H. Prevention of chronic pseudomonas aeruginosa infection by early inhalation therapy with tobramycin. Pediatric Pulmonology 1994;Suppl 10:255. [CENTRAL: 291534; CFGD Register: PI101a; CRS: 5500100000001553]
    1. Wiesemann HG, Steinkamp G, Ratjen F, Bauernfeind A, Przyklenk B, Doring G, et al. Placebo‐controlled, double‐blind, randomized study of aerosolized tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis. Pediatric Pulmonology 1998;25(2):88‐92. [CENTRAL: 682749; CFGD Register: PI101b; CRS: 5500100000003296; EMBASE: 1998078952; PUBMED: 9516091] - PubMed

References to studies awaiting assessment

OPTIMIZE 2018 {published data only}
    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; DOI: 10.1164/rccm.201802-0215OC; PUBMED: 29890086] - DOI - PMC - PubMed
    1. Mayer‐Hamblett N, Retsch‐Bogart G, Kloster M, Accurso F, Rosenfeld M, Albers G, et al. Erratum: azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial [Erratum: Azithromycin for early Pseudomonas infection in cystic fibrosis. The OPTIMIZE randomized trial (American Journal of Respiratory and Critical Care Medicine (2018) 198 (1177–1187) DOI: 10.1164/rccm.201802‐0215OC)]. American Journal of Respiratory and Critical Care Medicine 2019;199(6):809. [CENTRAL: CN‐01967101; CFGD REgister: MA31d; CRS: 11932900; DOI: 10.1164/rccm.201802-0215OC; EMBASE: 2001700512; PUBMED: 30874457] - DOI - PMC - PubMed
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    1. Ramsey BW, Retsch‐Bogart GZ, Kloster M, Buckingham R, Hamblett NM. Efficacy and safety of azithromycin for treatment of early pseudomonas in cystic fibrosis: the OPTIMIZE trial. Pediatric Pulmonology 2017;52 Suppl 47:380‐1. [Abstract no. : 434; CFGD Register: MA31a]

References to ongoing studies

Larsson 2011 {published data only}
    1. EUCTR2011‐000801‐39‐SE. Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis [www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2011‐000801‐39‐SE]. (first received 13 December 2011). [CFGD Register: PI252c]
    1. Kollberg H, Larsson A, Nilsson E. Anti‐pseudomonas IGY ready for phase III. Pediatric Pulmonology 2010;45 Suppl 33:343. [Abstract no.: 345; CENTRAL: 848799; CFGD Register: PI252a; CRS: 5500100000003664]
    1. Larsson A. Phase III study (IMPACTT) on anti‐pseudomonas IgY. Journal of Cystic Fibrosis 2011;10 Suppl 1:S24. [Abstract no.: 92; CENTRAL: 848800; CFGD Register: PI252b; CRS: 5500100000003666]
    1. NCT01455675. Efficacy study of igy (antibody against pseudomonas) in cystic fibrosis patients [Phase III study to evaluate clinical efficacy and safety of avian polyclonal anti‐pseudomonas antibodies (igy) in prevention of recurrence of pseudomonas aeruginosa infection in cystic fibrosis patients]. clinicaltrials.gov/show/nct01455675 (first received 2011 October 20). [CENTRAL: CN‐01533433; CFGD Register: PE252e; CRS: 8286130]
    1. Schuster A, Bend J, Hoiby N, Verde PE, Rottmann A, Larsson A, et al. Clinical study to evaluate an anti‐Pseudomonas aeruginosa IgY gargling solution (EUDRACT 2011‐000801‐39). Journal of Cystic Fibrosis 2019;18:S23. [Abstract no.: WS12‐5; CENTRAL: CN‐01990653; CFGD Register: PI252d; CRS: 12181829; EMBASE: 2001976053]

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