An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones.

Maria J G T VehreschildAnnie DucherThomas LouieOliver A CornelyCeline FegerAaron DaneMarina VarastetFabien VitryJean de GunzburgAntoine AndremontFrance MentréMark H Wilcox

Published in: The Journal of antimicrobial chemotherapy (2022)

In FQ-treated hospitalized patients, DAV132 was well tolerated, and FQ plasma concentrations unaffected. DAV132 preserved intestinal microbiota diversity and C. difficile colonization resistance.

Keyphrases

double blind
open label
placebo controlled
clinical trial
phase iii
study protocol
phase ii
cross sectional
clostridium difficile
randomized controlled trial
newly diagnosed