Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
Summary
Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA. Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit. Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.
Timeline
- Start
- 2011-04
- Primary completion
- 2015-01
- Completion
- 2015-05
Outcome
Met primary endpoint
Stopped (Enrollment): “Interim review showed a statistically significant treatment effect and the DMC recommended that the study be stopped with ongoing follow-up of enrolled subjects”
registry analysis (superiority test); Treatment vs Observation; p = 0.0004; Proportion Difference (Final Values) 0.525 (95% CI 0.23 to 0.80) NCT01349192 ↗
paper At day 28, 82% (n=18/22) of participants in the Rx arm compared with 26% (n=5/19) in the Obs arm were MRSA-negative. PMID 27852955 ↗
Publications
- Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.
- Muhlebach MS, Beckett V, Popowitch E, Miller MB, Baines A, Mayer-Hamblett N, Zemanick ET, Hoover WC, VanDalfsen JM, Campbell P, Goss CH; STAR-too study team. Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial. Thorax. 2017 Apr;72(4):318-326. doi: 10.1136/thoraxjnl-2016-208949. Epub 2016 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorhexidine gluconate | Other / unclassified | 0.12 % | Oral |
| Subject | Chlorhexidine gluconate | Other / unclassified | 2 % | Oral |
| Subject | Minocycline | Small molecule | 2 mg/kg | Oral |
| Subject | Minocycline | Small molecule | 100 mg | Oral |
| Subject | Mupirocin | Small molecule | 2 % | Intranasal |
| Subject | Mupirocin | Small molecule | 1 g | Intranasal |
| Subject | Rifampicin | Small molecule | 15 mg/kg | — |
| Subject | Rifampicin | Small molecule | 300 mg | — |
| Subject | Sulfamethoxazole | Small molecule | 40 mg/kg | — |
| Subject | Sulfamethoxazole | Small molecule | 1600 mg | — |
| Subject | Trimethoprim | Small molecule | 8 mg/kg | — |
| Subject | Trimethoprim | Small molecule | 320 mg | — |