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NCT03867136: TB-TRUST
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)
Phase 4 trial testing PZA sensitivity guided ultra-short all Oral Regimen in Multidrug Resistant Tuberculosis in 354 participants. Completed in 10 August 2024.
10 August 2024
Quick facts
| Lead sponsor | Huashan Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 354 |
| Start date | 1 June 2020 |
| Primary completion | 10 August 2024 |
| Estimated completion | 10 August 2024 |
| Sites | 13 locations across China |
Drugs / interventions tested
- PZA sensitivity guided ultra-short all Oral Regimen — full drug profile →
- Standardized Shorter Regimen — 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 levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36\~44 weeks) in subjects with multidrug-resistant tuberculosis (MDR-TB) compared to WHO standardized shorter regimen of 36-44 weeks.
Publications & conference data
8 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 -
Shortened tuberculosis treatment regimens: what is new?
Silva DR, Mello FCQ, Migliori GB. · · 2020 · cited 18× · PMID 32215450 · DOI 10.36416/1806-3756/e20200009 -
Refining MDR-TB treatment regimens for ultra short therapy (TB-TRUST): study protocol for a randomized controlled trial.
Weng T, Sun F, Li Y, Chen J, et al · · 2021 · cited 17× · PMID 33596848 · DOI 10.1186/s12879-021-05870-w -
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 -
A systematic review of endpoint definitions in late phase pulmonary tuberculosis therapeutic trials.
Hills NK, Lyimo J, Nahid P, Savic RM, et al · · 2021 · cited 10× · PMID 34344435 · DOI 10.1186/s13063-021-05388-1 -
At Long Last: Short, All-Oral Regimens for Multidrug-Resistant Tuberculosis in the United States.
Sinha P, Jacobson KR, Horsburgh CR, Acuña-Villaorduña C. · · 2023 · cited 9× · PMID 37125228 · DOI 10.1093/ofid/ofad177 -
Treatments of Multidrug-Resistant Tuberculosis: Light at the End of the Tunnel.
Lange C, Barry CE, Horsburgh CR. · · 2022 · cited 9× · PMID 35320062 · DOI 10.1164/rccm.202202-0393ed -
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 NCT03867136
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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.
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- 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 NCT03867136 (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/NCT03867136.
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