DECODE- Delpazolid Dose-Finding and Combination Development Trial

Study Director
InSook Cho
Start Date
10 / 2021
Trial Phase
Phase II
Trial Status
all patients enrolled
Current Enrollment
76 (15 Sept 2022)
Target Enrollment

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 randomized to one of five arms containing BDM standard doses with different doses of DZD (400, 800, 1200 mg QD).