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A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

NCT05306223 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2023-01-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.

Conditions

  • Tuberculosis, Multidrug-Resistant

Interventions

DRUG

Bedaquiline

Bedaquiline uncoated tablets will be administered orally.

DRUG

Levofloxacin

Levofloxacin filmcoated will be administered orally

DRUG

Linezolid

Linezolid tablets will be administered orally

DRUG

Cycloserine

Cycloserine capsules will be administered orally.

DRUG

Clofazimine

Clofazimine capsules will be administered orally.

DRUG

Pyrazinamide

Pyrazinamide tablets will be administered orally.

DRUG

Protionamide

Protionamide enteric-coated tablets will be administered orally.

Sponsors & Collaborators

  • Beijing Chest Hospital

    lead OTHER

Principal Investigators

  • Mengqiu Gao · Beijing Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2025-08-08
Completion
2025-08-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306223 on ClinicalTrials.gov