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CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial.

dc.contributor.author CAMERA2 study group and the Australasian Society for Infectious Diseases Clinical Research Network
dc.contributor.author Chatfield, M
dc.contributor.author Cheng, AC
dc.contributor.author Davis, JS
dc.contributor.author Fowler, Vance Garrison Jr
dc.contributor.author Howden, BP
dc.contributor.author Lipman, J
dc.contributor.author Lye, D
dc.contributor.author Nelson, J
dc.contributor.author O'Sullivan, M
dc.contributor.author Paterson, DL
dc.contributor.author Robinson, JO
dc.contributor.author Tong, SY
dc.contributor.author Van Hal, S
dc.contributor.author Yahav, D
dc.coverage.spatial England
dc.date.accessioned 2017-01-01T19:56:04Z
dc.date.issued 2016-03-31
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/27029920
dc.identifier 10.1186/s13063-016-1295-3
dc.identifier.uri https://hdl.handle.net/10161/13303
dc.description.abstract BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia is a serious infection resulting in 20-50 % 90-day mortality. The limitations of vancomycin, the current standard therapy for MRSA, make treatment difficult. The only other approved drug for treatment of MRSA bacteraemia, daptomycin, has not been shown to be superior to vancomycin. Surprisingly, there has been consistent in-vitro and in-vivo laboratory data demonstrating synergy between vancomycin or daptomycin and an anti-staphylococcal β-lactam antibiotic. There is also growing clinical data to support such combinations, including a recent pilot randomised controlled trial (RCT) that demonstrated a trend towards a reduction in the duration of bacteraemia in patients treated with vancomycin plus flucloxacillin compared to vancomycin alone. Our aim is to determine whether the addition of an anti-staphylococcal penicillin to standard therapy results in improved clinical outcomes in MRSA bacteraemia. METHODS/DESIGN: We will perform an open-label, parallel-group, randomised (1:1) controlled trial at 29 sites in Australia, New Zealand, Singapore, and Israel. Adults (aged 18 years or older) with MRSA grown from at least one blood culture and able to be randomised within 72 hours of the index blood culture collection will be eligible for inclusion. Participants will be randomised to vancomycin or daptomycin (standard therapy) given intravenously or to standard therapy plus 7 days of an anti-staphylococcal β-lactam (flucloxacillin, cloxacillin, or cefazolin). The primary endpoint will be a composite outcome at 90 days of (1) all-cause mortality, (2) persistent bacteraemia at day 5 or beyond, (3) microbiological relapse, or (4) microbiological treatment failure. The recruitment target of 440 patients is based on an expected failure rate for the primary outcome of 30 % in the control arm and the ability to detect a clinically meaningful absolute decrease of 12.5 %, with a two-sided alpha of 0.05, a power of 80 %, and assuming 10 % of patients will not be evaluable for the primary endpoint. DISCUSSION: Key potential advantages of adding anti-staphylococcal β-lactams to standard therapy for MRSA bacteraemia include their safety profile, low cost, and wide availability. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02365493 . Registered 24 February 2015.
dc.language eng
dc.relation.ispartof Trials
dc.relation.isversionof 10.1186/s13063-016-1295-3
dc.subject Cefazolin
dc.subject Cloxacillin
dc.subject Combination
dc.subject Daptomycin
dc.subject Flucloxacillin
dc.subject MRSA
dc.subject Methicillin-resistant
dc.subject Nafcillin
dc.subject Randomised controlled trial
dc.subject Staphylococcus aureus
dc.subject Vancomycin
dc.subject Anti-Bacterial Agents
dc.subject Australia
dc.subject Cefazolin
dc.subject Clinical Protocols
dc.subject Cloxacillin
dc.subject Daptomycin
dc.subject Drug Therapy, Combination
dc.subject Floxacillin
dc.subject Humans
dc.subject Israel
dc.subject Methicillin Resistance
dc.subject Methicillin-Resistant Staphylococcus aureus
dc.subject New Zealand
dc.subject Research Design
dc.subject Singapore
dc.subject Staphylococcal Infections
dc.subject Time Factors
dc.subject Treatment Outcome
dc.subject Vancomycin
dc.subject beta-Lactams
dc.title CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial.
dc.type Journal article
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/27029920
pubs.begin-page 170
pubs.organisational-group Basic Science Departments
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group Medicine
pubs.organisational-group Medicine, Infectious Diseases
pubs.organisational-group Molecular Genetics and Microbiology
pubs.organisational-group School of Medicine
pubs.publication-status Published online
pubs.volume 17
dc.identifier.eissn 1745-6215


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