NCT05381194 BPaL(M) Regimen for the Treatment of MDR/RR-TB
| NCT ID | NCT05381194 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Asan Medical Center |
| Condition | Multidrug- and Rifampicin-resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-12-13 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2022-12-13 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. At least 19 years old at enrolment 2. Bodyweight over 35Kg 3. If rifampicin resistance is confirmed through molecular or phenotypic drug susceptibility testing conducted on sputum or bronchoscopy specimens within 3 months of screening 4. Chest radiological findings consistent with pulmonary tuberculosis Exclusion Criteria: 1. Uncontrolled DM 2. Extrapulmonary TB that would require treatment longer than would be usual for pulmonary TB 3. Less than 30 Karnofsky score at enrolment 4. BMI less than 17 5. Known severe allergy to any of the BPaLM regimen drugs 6. Medical history of Glucose-galactose malabsorption, galactose intolerance, and Lapp lactase deficiency 7. HIV-positive 8. The QTcF interval exceeds 450 msec on the electrocardiogram at baseline 9. Patients who are at risk of Torsade de Pointes due to underlying heart diseases such as heart failure or arrhythmia 10. For women of childbearing potential if the pregnancy test is positive, women who are breastfeeding or planning to become pregnant within 6 months of discontinuation/termination of treatment during the study, or who do not want contraception (i.e., oral and subcutaneous hormonal contraceptives, condoms, diaphragms, intrauterine device, or use of appropriate contraceptive methods including abstinence) \*Note: Double contraception (e.g., when a male uses a barrier contraceptive method such as a condom, a female partner uses a hormonal contraceptive or an additional contraceptive method such as an intrauterine device) is required while taking the study drug and up to 6 months after stopping/terminating the study drug. In particular, taking the study drug may affect the efficacy of hormonal contraceptives, and even if you are using only barrier contraception at the same time with your partner, you cannot be sure of preventing pregnancy, so it is necessary to maintain double contraception. 11. Men who plan to become pregnant during the study period or within 6 months of discontinuation/termination of treatment, or who do not wish to use double contraception or abstinence during this period. 12. Patients who have Grade 3 or 4 or higher peripheral neuritis, or Grade 1 or 2 with a high probability of progression to peripheral neuritis, 13. Current use of monoamine oxidase Inhibitor or used 2 weeks before treatment 14. Use of serotonergic antidepressant within 3 days of treatment 15. Any contraindication that may affect QTc interval (amiodarone, chloroquine, chlorpromazine, clarithromycin, haloperidol, etc.) 16. Any contraindication that may cause myelosuppression 17. Taking drugs that affect the cytochrome P450 enzyme within 30 days (quinidine, tyramine, ketoconazole, fluconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan, etc.) 18. Previously treated with Bedaquiline or Linezolid for more than 4 weeks 19. Abnormal value of a blood test at baseline: * Hypokalemia, Hemoglobin \< 8.0 g/dL, Platelet \< 75,000/mm3, ANC \< 1000/mm3 * AST or ALT \> 3 X ULN, Total bilirubin \>2.0 X ULN, Albumin \< 3.2 mg/dL * Serum creatinine \> 2 X ULN, Serum calcium \< LLN, Serum magnesium \< LLN
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05381194 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Multidrug- and Rifampicin-resistant Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05381194 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05381194 currently recruiting?
Yes, NCT05381194 is actively recruiting participants. Contact the research team at shimts@amc.seoul.kr for enrollment information.
Where is the NCT05381194 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05381194 clinical trial?
NCT05381194 is sponsored by Asan Medical Center. The trial plans to enroll 80 participants.