Last reviewed · How we verify

NCT04717908: TB-TRUSTplus

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

Completed NA Last updated 12 November 2024
What this trial tests

NA trial testing Bedaquiline in Multidrug Resistant Tuberculosis in 89 participants. Completed in 22 June 2024.

Timeline
20 January 2021
Primary endpoint
22 June 2024
22 June 2024

Quick facts

Lead sponsorHuashan Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment89
Start date20 January 2021
Primary completion22 June 2024
Estimated completion22 June 2024
Sites15 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Huashan Hospital

Who can join

Adults 18 to 70, any sex, with Multidrug Resistant Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clofazimine for the treatment of tuberculosis.
    Stadler JAM, Maartens G, Meintjes G, Wasserman S. · · 2023 · cited 52× · PMID 36817137 · DOI 10.3389/fphar.2023.1100488
  2. Rapid Detection of Extensive Drug Resistance by Xpert MTB/XDR Optimizes Therapeutic Decision-Making in Rifampin-Resistant Tuberculosis Patients.
    Chen X, Li R, Ge S, Li Y, et al · · 2023 · cited 11× · PMID 37249422 · DOI 10.1128/jcm.01832-22
  3. Ability of the MeltPro MTB/PZA Assay to Detect Susceptibility to Pyrazinamide in Rifampin-Resistant Tuberculosis Patients.
    Li R, Li Y, Chen X, Jia L, et al · · 2023 · cited 2× · PMID 37162355 · DOI 10.1128/spectrum.04836-22

Verify or expand the search:

Other trials of Bedaquiline

Trials testing the same drug.

Other recruiting trials for Multidrug Resistant Tuberculosis

Currently open trials in the same condition.

Other Huashan Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04717908.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing