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NCT05306223: PROSPECT
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
Phase 4 trial testing Bedaquiline in Tuberculosis, Multidrug-Resistant in 212 participants. Status unknown.
8 August 2025
Quick facts
| Lead sponsor | Beijing Chest Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 212 |
| Start date | 10 May 2022 |
| Primary completion | 8 August 2025 |
| Estimated completion | 8 August 2025 |
| Sites | 17 locations across China |
Drugs / interventions tested
- Bedaquiline (bedaquiline) — full drug profile →
- Levofloxacin (Levofloxacin) — full drug profile →
- Linezolid — full drug profile →
- Cycloserine (CYCLOSERINE) — full drug profile →
- Clofazimine
- Pyrazinamide (PYRAZINAMIDE) — full drug profile →
- Protionamide
Conditions studied
- Tuberculosis, Multidrug-Resistant — all drugs for Tuberculosis, Multidrug-Resistant →
Sponsor
Beijing Chest Hospital
Who can join
Adults 18 to 65, any sex, with Tuberculosis, Multidrug-Resistant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 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 -
Advances of new drugs bedaquiline and delamanid in the treatment of multi-drug resistant tuberculosis in children.
Zhu H, Zhou X, Zhuang Z, Li L, et al · · 2023 · cited 11× · PMID 37384221 · DOI 10.3389/fcimb.2023.1183597 -
A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT.
Gao J, Gao M, Du J, Pang Y, et al · · 2024 · cited 1× · PMID 38561815 · DOI 10.1186/s13063-024-07946-9 -
Evaluation of an oral bedaquiline regimen for treating multidrug-resistant TB in China: a randomized trial.
Gao J, Huang Z, Ren F, Wu Y, et al · · 2026 · PMID 41925982 · DOI 10.1007/s15010-026-02734-w
Verify or expand the search:
- PubMed search for NCT05306223
- 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.
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- 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
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Other recruiting trials for Tuberculosis, Multidrug-Resistant
Currently open trials in the same condition.
- NCT05007821 — Linezolid Dosing Strategies in Drug-Resistant TB · Phase 2 · active not recruiting
- NCT05117788 — Bioneer Q-RFIA Clinical Evaluation · active not recruiting
- NCT05871489 — Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens · active not recruiting
- NCT02354014 — Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of M · Phase 2 · recruiting
- NCT01212003 — Training Protocol on the Natural History of Tuberculosis · recruiting
Other Beijing Chest Hospital trials
Trials by the same sponsor.
- NCT07372781 — Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease · Phase 2 · enrolling by invitation
- NCT07268664 — Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort · Phase 3 · not yet recruiting
- NCT06809413 — Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease · Phase 2 · enrolling by invitation
- NCT06764368 — Phase II Study of Adebrelimab, Chemotherapy, and Apatinib for Advanced Pulmonary Neuroendocrine Tumors · Phase 2 · not yet recruiting
- NCT06811025 — Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis · Phase 1, PHASE2 · enrolling by invitation
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 NCT05306223 (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 Beijing Chest Hospital
- Last refreshed: 18 January 2023
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/NCT05306223.
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