Please use this identifier to cite or link to this item: https://doi.org/10.1186/1745-6215-15-233
Title: Vancomycin versus daptomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteremia due to isolates with high vancomycin minimum inhibitory concentrations: Study protocol for a phase IIB randomized controlled trial
Authors: Kalimuddin, S 
Phillips, R
Gandhi, M 
de Souza, N.N 
Low, J.G.H 
Archuleta, S 
Lye, D 
Tan, T.T 
Keywords: daptomycin
vancomycin
antiinfective agent
daptomycin
vancomycin
adult
antibiotic therapy
article
bacterium isolate
blood culture
bloodstream infection
clinical article
comparative effectiveness
controlled study
drug efficacy
drug safety
female
hospital patient
human
intention to treat analysis
male
methicillin resistant Staphylococcus aureus
methicillin resistant Staphylococcus aureus infection
minimum inhibitory concentration
mortality
multicenter study (topic)
open study
phase 2 clinical trial (topic)
pilot study
prospective study
randomized controlled trial (topic)
staphylococcal bacteremia
bacteremia
clinical trial
comparative study
drug administration
drug effects
methicillin resistant Staphylococcus aureus
methodology
microbial sensitivity test
multicenter study
phase 2 clinical trial
randomized controlled trial
Staphylococcal Infections
young adult
Anti-Bacterial Agents
Bacteremia
Daptomycin
Drug Administration Schedule
Humans
Methicillin-Resistant Staphylococcus aureus
Microbial Sensitivity Tests
Pilot Projects
Prospective Studies
Research Design
Staphylococcal Infections
Vancomycin
Young Adult
Issue Date: 2014
Citation: Kalimuddin, S, Phillips, R, Gandhi, M, de Souza, N.N, Low, J.G.H, Archuleta, S, Lye, D, Tan, T.T (2014). Vancomycin versus daptomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteremia due to isolates with high vancomycin minimum inhibitory concentrations: Study protocol for a phase IIB randomized controlled trial. Trials 15 (1) : 233. ScholarBank@NUS Repository. https://doi.org/10.1186/1745-6215-15-233
Rights: Attribution 4.0 International
Abstract: Background: Vancomycin is the standard first-line treatment for methicillin-resistant Staphylococcus aureus bacteremia. However, recent consensus guidelines recommend that clinicians consider using alternative agents such as daptomycin when the vancomycin minimum inhibitory concentration is greater than 1 ug/ml. To date however, there have been no head-to-head randomized trials comparing the safety and efficacy of daptomycin and vancomycin in the treatment of such infections. The primary aim of our study is to compare the efficacy of daptomycin versus vancomycin in the treatment of bloodstream infections due to methicillin-resistant Staphylococcus aureus isolates with high vancomycin minimum inhibitory concentrations (greater than or equal to 1.5 ug/ml) in terms of reducing all-cause 60-day mortality.Methods/Design: The study is designed as a multicenter prospective open label phase IIB pilot randomized controlled trial. Eligible participants will be inpatients over 21-years-old with a positive blood culture for methicillin-resistant Staphylococcus aureus with vancomycin minimum inhibitory concentration of greater than or equal to 1.5ug/ml. Randomization into intervention or active control arms will be performed with a 1:1 allocation ratio. We aim to recruit 50 participants over a period of two years. Participants randomized to the active control arm will receive vancomycin dose-while those randomized to the intervention arm will receive daptomycin. Participants will receive a minimum of 14 days study treatment.The primary analysis will be conducted on the intention-to-treat principle. The Fisher's exact test will be used to compare the 60-day mortality rate from index blood cultures (primary endpoint) between the two treatment arms, and the exact two-sided 95% confidence interval will be calculated using the Clopper and Pearson method. Primary analysis will be conducted using a two sided alpha of 0.05.Discussion: If results from this pilot study suggest that daptomycin shows significant efficacy in the treatment of bloodstream infections due to methicillin-resistant Staphylococcus aureus isolates with high vancomycin minimum inhibitory concentrations, we aim to proceed with a larger scale confirmatory study. This would help guide clinicians and inform practice guidelines on the optimal treatment for such infections.Trial registration: The trial is listed on clinicaltrials.gov (NCT01975662, date of registration: 29 October 2013). © 2014 Kalimuddin et al.; licensee BioMed Central Ltd.
Source Title: Trials
URI: https://scholarbank.nus.edu.sg/handle/10635/181750
ISSN: 17456215
DOI: 10.1186/1745-6215-15-233
Rights: Attribution 4.0 International
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