Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND) : a randomised, controlled, open-label, phase 3b/4 trial

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EXTEND Clinical Study Grp 2018 , ' Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND) : a randomised, controlled, open-label, phase 3b/4 trial ' , Lancet Infectious Diseases , vol. 18 , no. 3 , pp. 296-307 . https://doi.org/10.1016/S1473-3099(17)30751-X

Title: Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND) : a randomised, controlled, open-label, phase 3b/4 trial
Author: EXTEND Clinical Study Grp
Date: 2018-03
Language: eng
Number of pages: 12
Belongs to series: Lancet Infectious Diseases
ISSN: 1473-3099
URI: http://hdl.handle.net/10138/300988
Abstract: Background Clostridium difficile infection causes severe complications and frequently recurs. An extended-pulsed fidaxomicin regimen might facilitate sustained clinical cure by prolonging C difficile suppression and supporting gut microbiota recovery. We aimed to compare clinical outcomes of extended-pulsed fidaxomicin with standard vancomycin. Methods In this randomised, controlled, open-label, superiority study, we recruited hospitalised adults aged 60 years and older with confirmed C difficile infection at 86 European hospitals. Patients were randomly assigned (1: 1) using an interactive web response system to receive extended-pulsed fidaxomicin (200 mg oral tablets, twice daily on days 1-5, then once daily on alternate days on days 7-25) or vancomycin (125 mg oral capsules, four times daily on days 1-10), stratified by baseline C difficile infection severity, cancer presence, age (>= 75 years vs Findings Between Nov 6, 2014, and May 5, 2016, 364 patients were enrolled and randomly assigned to receive extended-pulsed fidaxomicin or vancomycin. 362 patients received at least one dose of study medication (181 in each group). 124 (70%) of 177 patients in the modified full analysis set receiving extended-pulsed fidaxomicin achieved sustained clinical cure 30 days after end of treatment, compared with 106 (59%) of 179 patients receiving vancomycin (difference 11% [95% CI 1.0-20.7], p=0.030; odds ratio 1.62 [95% CI 1.04-2.54]). Incidence of treatment-emergent adverse events did not differ between extended-pulsed fidaxomicin (121 [67%] of 181) and vancomycin (128 [71%] of 181) treatment arms. One death in the vancomycin arm was considered by the investigator to be related to study drug. Interpretation Extended-pulsed fidaxomicin was superior to standard-dose vancomycin for sustained cure of C difficile infection, and, to our knowledge, extended-pulsed fidaxomicin recurrence rates in this study are the lowest observed in a randomised clinical trial of antibiotic treatment for C difficile infection.
Subject: HUMAN GUT MODEL
INTESTINAL MICROBIOTA
DOSING REGIMENS
PREVENTION
RECURRENCE
EFFICACY
BURDEN
3121 General medicine, internal medicine and other clinical medicine
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