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NCT05381194
The 6-month BPaL(M) Regimen for the Treatment of Patients With MDR/RR-TB: Multicenter, Single-arm, Operational Research, Clinical Trial
Phase 4 trial testing BPaL(M) regimen in Multidrug- and Rifampicin-resistant Tuberculosis in 80 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 13 December 2022 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- BPaL(M) regimen — full drug profile →
Conditions studied
- Multidrug- and Rifampicin-resistant Tuberculosis — all drugs for Multidrug- and Rifampicin-resistant Tuberculosis →
Sponsor
Asan Medical Center
Who can join
19 and older, any sex, with Multidrug- and Rifampicin-resistant Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
A microbiological failure or clinical failure or relapse
Time frame: until 12 months after the end of treatment
A microbiological failure or clinical failure or relapse during the treatment period and the 12-month follow-up period after end of treatment
Sponsor's own description
The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid, Linezolid for 26 weeks for the treatment of MDR/RR-TB through the clinical trial.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Establishing the Safety and Efficacy of Bedaquiline-Containing Regimen for the Treatment of Drug-Resistant Tuberculosis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
Jihwaprani MC, Sun Y, Rizky WC, Sula I, et al · · 2024 · cited 2× · PMID 39157539 · DOI 10.1155/2024/5542658
Verify or expand the search:
- PubMed search for NCT05381194
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Asan Medical Center trials
Trials by the same sponsor.
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- NCT07489092 — Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge · NA · recruiting
- NCT07431762 — Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Hear · Phase 4 · 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 NCT05381194 (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 Asan Medical Center
- Last refreshed: 13 March 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/NCT05381194.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing