BPaL(M) Regimen for the Treatment of MDR/RR-TB

NCT05381194 | Recruiting Phase 4 DMC

• 1 other identifier: BPaL(M)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Multidrug- and Rifampicin-resistant Tuberculosis

Outcome Measures

Primary Outcomes (1)

• A microbiological failure or clinical failure or relapse

  A microbiological failure or clinical failure or relapse during the treatment period and the 12-month follow-up period after end of treatment

  until 12 months after the end of treatment

Secondary Outcomes (4)

• Time to sputum culture conversion during the treatment period

  26 weeks or 24 weeks

• Proportion of culture-negative patients at specific times (weeks 4, 8, 12, 16, and 24 or 26)

  26 weeks or 24 weeks

• Prescribed dose of Linezolid

  26 weeks or 24 weeks

• All-cause mortality

  26 weeks or 24 weeks

Study Arms (1)

single arm (investigational arm)

EXPERIMENTAL

BPaLM

Drug: BPaL(M) regimen

Interventions

BPaL(M) regimen DRUG

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

single arm (investigational arm)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 19 years old at enrolment
• Bodyweight over 35Kg
• If rifampicin resistance is confirmed through molecular or phenotypic drug susceptibility testing conducted on sputum or bronchoscopy specimens within 3 months of screening
• Chest radiological findings consistent with pulmonary tuberculosis

You may not qualify if:

• Uncontrolled DM
• Extrapulmonary TB that would require treatment longer than would be usual for pulmonary TB
• Less than 30 Karnofsky score at enrolment
• BMI less than 17
• Known severe allergy to any of the BPaLM regimen drugs
• Medical history of Glucose-galactose malabsorption, galactose intolerance, and Lapp lactase deficiency
• HIV-positive
• The QTcF interval exceeds 450 msec on the electrocardiogram at baseline
• Patients who are at risk of Torsade de Pointes due to underlying heart diseases such as heart failure or arrhythmia
• 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.
• 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.
• 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,
• Current use of monoamine oxidase Inhibitor or used 2 weeks before treatment
• Use of serotonergic antidepressant within 3 days of treatment

Sponsors & Collaborators

• Asan Medical Center: lead
• Pusan National University Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Chonnam National University Hospital: collaborator
• The Catholic University of Korea: collaborator
• Chungbuk National University Hospital: collaborator
• Ulsan University Hospital: collaborator
• Soon Chun Hyang University: collaborator
• Incheon St.Mary's Hospital: collaborator
• DongGuk University: collaborator
• National Medical Center, Seoul: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Tae Sun Shim, MD, PhD

CONTACT

+82-2-3010-3892; shimts@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor, MD, PhD

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 19, 2022
• Study Start: December 13, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)