Trial

DECODE- Delpazolid Dose-Finding and Combination Development Trial

Study Director
InSook Cho
Start Date
10 / 2021
Trial Phase
Phase II
Trial Status
enrolling
Current Enrollment
41 (March 2022)
Target Enrollment
75
Overview

This is an open label Phase IIb dose-finding, randomized, controlled study with a duration of 16 weeks of experimental therapy of Delpazolid (DZD) - Bedaquiline/Delamanid/ Moxifloxacin (BDM) in adult patients with newly diagnosed, smear positive, uncomplicated, drug sensitive pulmonary tuberculosis (TB) to evaluate the safety, efficacy, tolerability, pharmacokinetics and exposure/response-relationship of different doses of delpazolid in combination with bedaquiline, delamanid and moxifloxacin.

Participants will be randomized to one of five arms containing BDM standard dose with different doses of DZD.