New treatment regimen for multidrug-resistant tuberculosis
The 6-month BPaL(M) Regimen for the Treatment of Patients With MDR/RR-TB: Multicenter, Single-arm, Operational Research, Clinical Trial
This study is testing a new combination of medications to see if it can help Korean patients with multidrug-resistant tuberculosis get better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | doxorubicin |
| Locations | 1 site (Seoul, Songpa-gu) |
| Trial ID | NCT05381194 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of the BPaL(M) regimen, which includes Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin, for treating multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) in Korean patients. Participants will receive either a 24-week or 26-week treatment course, depending on their specific regimen. The study builds on previous successful trials, such as NixTB and ZeNix, to assess the effectiveness of this combination therapy in a targeted population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with confirmed rifampicin resistance and pulmonary tuberculosis.
Not a fit: Patients with uncontrolled diabetes, severe allergies to the treatment drugs, or certain heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from MDR/RR-TB.
How similar studies have performed: Previous studies have shown success with similar regimens, indicating a promising approach for treating MDR/RR-TB.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Songpa-gu
- Asan Medical Center — Seoul, Songpa-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Tae Sun Shim, MD, PhD
- Email: shimts@amc.seoul.kr
- Phone: +82-2-3010-3892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.