Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2022-12-13
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm (investigational arm)
BPaLM
BPaL(M) regimen
Patients diagnosed with MDR/RR-TB are initially assigned to the BPaLM regimen as a single-arm for treatment initiation. Afterward, if MDR/RR-TB is confirmed to be fluoroquinolone-resistant by molecular or phenotypic DST, the treatment is switched to the BPaL regimen (for 24 weeks). On the other hand, if MDR/RR-TB is confirmed to be fluoroquinolone-susceptible, treatment for MDR/RR-TB is maintained with the BPaLM regimen (for 26 weeks).
The dosage of each medication is as follows:
* Bedaquiline 400mg/day for the 2 weeks, 200mg/TIW afterward
* Pretomanid 200mg/day
* Linezolid 600mg/day for the 9weeks, 300mg/day afterward
* Moxifloxacin 400mg/day
Interventions
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BPaL(M) regimen
Patients diagnosed with MDR/RR-TB are initially assigned to the BPaLM regimen as a single-arm for treatment initiation. Afterward, if MDR/RR-TB is confirmed to be fluoroquinolone-resistant by molecular or phenotypic DST, the treatment is switched to the BPaL regimen (for 24 weeks). On the other hand, if MDR/RR-TB is confirmed to be fluoroquinolone-susceptible, treatment for MDR/RR-TB is maintained with the BPaLM regimen (for 26 weeks).
The dosage of each medication is as follows:
* Bedaquiline 400mg/day for the 2 weeks, 200mg/TIW afterward
* Pretomanid 200mg/day
* Linezolid 600mg/day for the 9weeks, 300mg/day afterward
* Moxifloxacin 400mg/day
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Pusan National University Hospital
OTHER
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Severance Hospital
OTHER
Chonnam National University Hospital
OTHER
The Catholic University of Korea
OTHER
Chungbuk National University Hospital
OTHER
Ulsan University Hospital
OTHER
Soon Chun Hyang University
OTHER
Incheon St.Mary's Hospital
OTHER
DongGuk University
OTHER
National Medical Center, Seoul
OTHER
Asan Medical Center
OTHER
Responsible Party
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Tae Sun Shim
Clinical professor, MD, PhD
Locations
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Asan Medical Center
Seoul, Songpa-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BPaL(M)
Identifier Type: -
Identifier Source: org_study_id
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