Multicentre open-label randomised controlled trial comparing the efficacy and safety of colistin-based combination therapy with the best available therapy for treating hospital-acquired pneumonia or bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (COUNT-CRE): a study protoco
Abstract
Introduction The prevalence of carbapenem-resistant Enterobacteriaceae (CRE) infections is increasing worldwide. However, the evidence regarding the treatment of infections caused by CRE is either low or conditional. Methods and analysis This multicentre, investigator-initiated, open-label, randomised controlled, non-inferiority trial compares colistin-based combination therapy with the best available therapy for treating CRE infections. This study is being conducted at 15 centres in China. We include participants with hospital-acquired pneumonia (HAP) or bloodstream infections (BSI) caused by CRE. Participants will be randomly assigned to a colistin-based combination therapy group or the best available therapy group. The primary outcome is the 14-day all-cause mortality. Secondary outcomes include 14-day clinical cure rate, 14-day efficacy rate, intensive care unit (ICU)-free days within 28 days after randomisation, 14-day microbiological cure rate, incidence of adverse events (AEs) and serious AEs within the first 28 days, hospital mortality, 28-day all-cause mortality and ICU mortality. A target sample size of 404, with 322 evaluable patients (161 in each group) allowed for at least 80% power (one-sided significance level of 0.025), assuming a 15% non-inferiority margin and a 14-day all-cause mortality rate of 35% in both groups. Primary outcome will be assessed based on the microbiologically modified intent-to-treat, and one interim analysis is planned when 50% of the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 322 participants or records.
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