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. 2018 Jul 21;7(7):CD009650.
doi: 10.1002/14651858.CD009650.pub4.

Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis

David Kh Lo  1 , Marianne S Muhlebach, Alan R Smyth
Affiliations

Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis

David Kh Lo et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Cystic fibrosis is an inherited recessive disorder of chloride transport that is characterised by recurrent and persistent pulmonary infections from resistant organisms that result in lung function deterioration and early mortality in sufferers.Meticillin-resistant Staphylococcus aureus (MRSA) has emerged as, not only an important infection in people who are hospitalised, but also as a potentially harmful pathogen in cystic fibrosis. Chronic pulmonary infection with MRSA is thought to confer people with cystic fibrosis with a worse clinical outcome and result in an increased rate of lung function decline. Clear guidance for MRSA eradication in cystic fibrosis, supported by robust evidence, is urgently needed. This is an update of a previous review.

Objectives: To evaluate the effectiveness of treatment regimens designed to eradicate MRSA and to determine whether the eradication of MRSA confers better clinical and microbiological outcomes for people with cystic fibrosis. To ascertain whether attempts at eradicating MRSA can lead to increased acquisition of other resistant organisms (including P aeruginosa) or increased adverse effects from drugs, or both.

Search methods: Randomised and quasi-randomised controlled trials were identified by searching the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, PubMed, MEDLINE, clinical trial registries (Clinicaltrials.gov, WHO ICTRP, ISRCTN Registry), handsearching article reference lists and through contact with experts in the field.Date of the last search of the Group's Cystic Fibrosis Trials Register: 27 July 2017.Ongoing trials registries were last searched: 07 August 2017.

Selection criteria: Randomised or quasi-randomised controlled trials comparing any combinations of topical, inhaled, oral or intravenous antimicrobials with the primary aim of eradicating MRSA compared with placebo, standard treatment or no treatment.

Data collection and analysis: The authors independently assessed all search results for eligibility. They used the GRADE methodology to assess the quality of the evidence.

Main results: The review includes two trials with a total of 106 participants with MRSA infection. In both trials the active treatment was oral trimethoprim and sulfamethoxazole combined with rifampicin; however, one trial administered this combination for two weeks alongside nasal, skin and oral decontamination and a three-week environmental decontamination, while the second trial administered this drug combination for 21 days with five days intranasal mupirocin. In both trials the control arm was observation only.Both trials reported successful eradication of MRSA in people with CF as an outcome; however, the definition used for MRSA eradication differed. The first trial (n = 45) defined MRSA eradication as negative MRSA respiratory cultures at day 28, and reported that, when compared to control, oral trimethoprim and sulfamethoxazole combined with rifampicin may lead to a higher proportion of negative cultures, odds ratio (OR) 12.6 (95% confidence interval (CI) 2.84 to 55.84; low-certainty evidence); however, by day 168 of follow-up there was no difference in the proportion of participants who remained MRSA-negative in either treatment arm, OR 1.17 (95% CI 0.31 to 4.42) (low-quality evidence). In the second trial, successful eradication was defined as the absence of MRSA following treatment (oral co-trimoxazole and rifampicin with intranasal mupirocin or observation) in at least three cultures over a period of six months. At the time of reporting, 40 out of 61 participants had completed follow-up, but results showed no difference between groups. Eradication was achieved in 12 out 29 participants (41%) receiving active treatment, and in 9 out of 32 participants (28%) on the observation arm, OR 1.80 (95% CI 0.62 to 5.25) (very low-quality evidence).With regards to this review's secondary outcomes, these were reported in the first trial only. The trial reports that no differences were observed between the two arms in terms of pulmonary exacerbations (from screening to day 28), nasal colonisation, lung function, weight or participant-reported outcomes. While not a specific outcome of this review, investigators reported that the rate of hospitalisation from screening through day 168 was lower with oral trimethoprim and sulfamethoxazole combined with rifampicin compared to control, rate ratio 0.22 (95% CI 0.05 to 0.72) (P = 0.0102).

Authors' conclusions: Early eradication of MRSA is possible in people with cystic fibrosis, with one trial demonstrating superiority of active MRSA treatment compared with observation only in terms of the proportion of MRSA-negative respiratory cultures at day 28. However, by six months, the proportion of participants who remained MRSA-negative did not differ between treatment arms in either trial. Moreover, the longer-term clinical consequences in terms of lung function, mortality and cost of care, remain unclear.Using GRADE methodology, we judged the quality of the evidence provided by this review to be very low to low, due to potential biases from the open-label design and unclear detail reported in one trial. Based on the available evidence, it is the opinion of the authors that whilst early eradication of respiratory MRSA in people with cystic fibrosis is possible, there is not currently enough evidence regarding the clinical outcomes of eradication to support the use of the interventions studied.

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Conflict of interest statement

David Lo: none known.

Marianne Muhlebach is one of the principle investigators for a randomised controlled trial evaluating early treatment of MRSA (Muhlebach 2017).

Alan Smyth is the Co‐ordinating Editor of the Cochrane Cystic Fibrosis and Genetic Disorders Group and declares relevant activities of: membership of a REMPEX steering committee; consultancies for Novartis, Biocontrol and Rempex Pharma (both make aerosolised antibiotics which are active against some strains of Staphylococcus aureus); and also a lecture paid for by Chiesi Pharma.

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.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Sharma 2016 {published data only}
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Vallieres 2016 {published data only}
    1. Vallières E, Rendall JC, Moore JE, McCaughan J, Hoeritzauer AI, Tunney MM, et al. MRSA eradication of newly acquired lower respiratory tract infection in cystic fibrosis. ERJ Open Research 2016;2(1):pii: 00064‐2015. [DOI: 10.1183/23120541.00064-2015] - DOI - PMC - PubMed
Vanderhelst 2013 {published data only}
    1. Vanderhelst E, Wachter E, Willekens J, Piérard D, Vincken W, Malfroot A. Eradication of chronic methicillin‐resistant Staphylococcus aureus infection in cystic fibrosis patients. An observational prospective cohort study of 11 patients. Journal of Cystic Fibrosis 2013;12(6):662‐6. - PubMed
Van Devanter 2014 {published data only}
    1. Fischer R, Flume PA, 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: CN‐01262259; CFGD Register: PI283d; CRS: 5170002]
    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: CN‐01171477; CFGD Register: PI283e; CRS: 4378591]
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    1. NCT01270347. Trial of aeroquin versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients [Phase 3, open‐label, randomized trial to evaluate the safety and efficacy of MP‐376 inhalation solution (Aeroquin) vs. tobramycin inhalation solution (TIS) in stable CF patients]. clinicaltrials.gov/ct2/show/NCT01270347 05 January 2011. [CENTRAL: CN‐01012530; CFGD Register: PI283a; clinicaltrials.gov: NCT01270347; CRS: 1743147]
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References to studies awaiting assessment

Dasenbrook 2015 {published data only}
    1. Dasenbrook EC. Emerging therapies in cystic fibrosis: aerovanc for the treatment of chronic MRSA. Pediatric Pulmonology 2015;50 Suppl 41:149. [Abstract no: S11.4; CENTRAL: 1092196; CFGD Register: PI289a; CRS: 5500135000001385]
    1. Marich C, Lord J, Dasenbrook EC, Flume PA, Jouhikainen T. Pharmacokinetics of vancomycin in plasma and sputum following pulmonary administration in cystic fibrosis patients with persistent methicillin‐resistant Staphylococcus aureus infection. Pediatric Pulmonology 2016;51 Suppl 45:298‐99. [Abstract no: 282; CENTRAL: 1212605; CFGD Register: PI289b; CRS: 5500135000002071; EMBASE: 612358635]
    1. NCT01746095. Efficacy and safety study of AeroVanc for the treatment of persistent MRSA lung infection in cystic fibrosis patients [A phase 2, randomized, double blind, placebo‐controlled study of AeroVanc for the treatment of persistent methicillin‐resistant staphylococcus aureus lung Infection in cystic fibrosis patients]. clinicaltrials.gov/ct2/show/NCT01746095 10 December 2012.

References to ongoing studies

Dasenbrook 2012 {published data only}
    1. Dasenbrook EC. Design of a clinical trial to eradicate persistent MRSA: The path from hypothesis to implementation. Pediatric Pulmonology 2012;47 Suppl:123‐4. [CENTRAL: 1004547; CFGD Register: PI285c; CRS: 5500135000001960; EMBASE: 70891676]
    1. Dezube R, Jennings M, Rykiel M, Weaver D, Boyle MP, Dasenbrook E. Update on the persistent methicillin‐resistant Staphylococcus aureus eradication protocol (PMEP) trial. Pediatric Pulmonology 2015;50 Suppl 41:314. [Abstract no: 327; CENTRAL: 1092176; CFGD Register: PI285b; CRS: 5500135000001372]
    1. Jennings MT, Boyle MP, Weaver D, Callahan KA, Dasenbrook EC. Eradication strategy for persistent methicillin‐resistant Staphylococcus aureus infection in individuals with cystic fibrosis‐the PMEP trial: study protocol for a randomized controlled trial. Trials 2014;15(1):223. [CENTRAL: 995772; CFGD Register: PI285a; CRS: 5500050000000166; DOI: 10.1186/1745-6215-15-223; EMBASE: 2014424291] - DOI - PMC - PubMed
    1. NCT01594827. Persistent methicillin resistant Staphylococcus aureus eradication protocol (PMEP) [Persistent MRSA eradication protocol (PMEP)]. clinicaltrials.gov/ct2/show/NCT01594827 09 May 2012.

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References to other published versions of this review

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