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NCT04717908: TB-TRUSTplus
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS
NA trial testing Bedaquiline in Multidrug Resistant Tuberculosis in 89 participants. Completed in 22 June 2024.
22 June 2024
Quick facts
| Lead sponsor | Huashan Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 20 January 2021 |
| Primary completion | 22 June 2024 |
| Estimated completion | 22 June 2024 |
| Sites | 15 locations across China |
Drugs / interventions tested
- Bedaquiline (bedaquiline) — full drug profile →
- Pyrazinamide (PYRAZINAMIDE) — full drug profile →
- Linezolid — full drug profile →
- Cycloserine (CYCLOSERINE) — full drug profile →
- Clofazimine (clofazimine) — full drug profile →
Conditions studied
- Multidrug Resistant Tuberculosis — all drugs for Multidrug Resistant Tuberculosis →
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):
-
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 -
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 -
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:
- PubMed search for NCT04717908
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bedaquiline
Trials testing the same drug.
- NCT06192160 — Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2 · recruiting
- NCT06081361 — Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezol · Phase 3 · active not recruiting
- NCT05766267 — Short-course Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2, PHASE3 · active not recruiting
- NCT05824871 — A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients · Phase 3 · recruiting
- NCT05382312 — Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established A · Phase 2 · completed
Other recruiting trials for Multidrug Resistant Tuberculosis
Currently open trials in the same condition.
- NCT05081401 — Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tube · Phase 3 · recruiting
Other Huashan Hospital trials
Trials by the same sponsor.
- NCT07469735 — Vorasidenib Guided by AGX PET in Recurrent/Low-grade Glioma · NA · not yet recruiting
- NCT07364487 — This is an Open-Label Study to Assess the Safety and Efficacy of GC012F in Patients With Multiple Sclerosis · EARLY_PHASE1 · withdrawn
- NCT07369830 — The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function · NA · recruiting
- NCT07185373 — Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL · Phase 2, PHASE3 · not yet recruiting
- NCT07075029 — RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04717908 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Huashan Hospital
- Last refreshed: 12 November 2024
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