Please use this identifier to cite or link to this item: https://doi.org/10.1186/S13063-016-1295-3
Title: CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: Study protocol for a randomised controlled trial
Authors: Tong, S.Y.C
Nelson, J
Paterson, D.L
Fowler, V.G
Howden, B.P
Cheng, A.C
Chatfield, M
Lipman, J
Van Hal, S
O'Sullivan, M
Robinson, J.O
Yahav, D
Lye, D 
Davis, J.S
CAMERA2 study group and the Australasian Society for Infectious Diseases Clinical Research Netwo
Keywords: cefazolin
cloxacillin
daptomycin
flucloxacillin
penicillin derivative
vancomycin
antiinfective agent
beta lactam
cefazolin
cloxacillin
daptomycin
flucloxacillin
vancomycin
adult
antibiotic therapy
Article
Australia
bacterial load
blood culture
controlled study
drug cost
drug safety
health care availability
human
Israel
major clinical study
methicillin resistant Staphylococcus aureus infection
mortality
New Zealand
open study
parallel design
randomized controlled trial
relapse
Singapore
treatment duration
treatment failure
treatment outcome
clinical protocol
clinical trial
combination drug therapy
drug effects
isolation and purification
methicillin resistant Staphylococcus aureus
methodology
microbiology
multicenter study
pathogenicity
penicillin resistance
Staphylococcal Infections
time factor
Anti-Bacterial Agents
Australia
beta-Lactams
Cefazolin
Clinical Protocols
Cloxacillin
Daptomycin
Drug Therapy, Combination
Floxacillin
Humans
Israel
Methicillin Resistance
Methicillin-Resistant Staphylococcus aureus
New Zealand
Research Design
Singapore
Staphylococcal Infections
Time Factors
Treatment Outcome
Vancomycin
Issue Date: 2016
Citation: Tong, S.Y.C, Nelson, J, Paterson, D.L, Fowler, V.G, Howden, B.P, Cheng, A.C, Chatfield, M, Lipman, J, Van Hal, S, O'Sullivan, M, Robinson, J.O, Yahav, D, Lye, D, Davis, J.S, CAMERA2 study group and the Australasian Society for Infectious Diseases Clinical Research Netwo (2016). CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: Study protocol for a randomised controlled trial. Trials 17 (1) : 170. ScholarBank@NUS Repository. https://doi.org/10.1186/S13063-016-1295-3
Rights: Attribution 4.0 International
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. © 2016 Tong et al.
Source Title: Trials
URI: https://scholarbank.nus.edu.sg/handle/10635/179951
ISSN: 17456215
DOI: 10.1186/S13063-016-1295-3
Rights: Attribution 4.0 International
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