BTZ-043 Dose Evaluation in Combination and Selection
Conditions:   Tuberculosis, Pulmonary;   Other Specified Pulmonary Tuberculosis Interventions:   Drug: BTZ-043;   Drug: Bedaquiline;   Drug: Delamanid;   Drug: Moxifloxacin Sponsors:   Michael Hoelscher;   Radboud University Medical Center;   University of California, San Francisco;   University College, London Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 3, 2023 Category: Research Source Type: clinical trials

A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis
DiscussionDECODE is an innovative dose-finding trial, designed to support exposure-response modelling for safe and effective dose selection. The trial design allows assessment of occurrence of late toxicities as observed with linezolid, which is necessary in clinical evaluation of novel oxazolidinones. The primary efficacy endpoint is the change in bacterial load, an endpoint conventionally used in shorter dose-finding trials. Long-term follow-up after shortened treatment is possible through a safety rule excluding slow-and non-responders from potentially poorly performing dosages.Trial registrationDECODE was registered in...
Source: Trials - June 6, 2023 Category: Research Source Type: clinical trials

Sudapyridine (WX-081) in RR-TB Patients
Condition:   Rifampicin-resistant Tuberculosis Interventions:   Drug: Sudapyridine;   Drug: Bedaquiline Sponsor:   Shanghai Jiatan Pharmatech Co., Ltd Enrolling by invitation (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 24, 2023 Category: Research Source Type: clinical trials