drugset / Trial / NCT05040126
Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India
Phase 3
Unknown
400 enrolled
Tuberculosis Research Centre, India
Govt Medical College & Hospital, Bhavnagar · collabGovt. Medical College & Hospital, Surat · collabGovt.Rajaji Medical college and hospital, Madurai · collabInternational Union Against Tuberculosis and Lung Diseases · collabKing George's Medical College and Hospital, Lucknow · collabNational Institute of Tuberculosis and Respiratory Diseases, New Delhi · collabRajan Babu Institute of Pulmonary Medicine and Tuberculosis, Delhi · collabSN Medical College, Agra · collabSarvodaya Charitable Trust Hospital, Ghatkopar, Mumbai · collabShatabdi Centenary Hospital, Govandi, Mumbai · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Existing problem with DR TB management: Injectable regimens for longer duration with toxicity Poor adherence, treatment failures, continued transmission Need of the study: Oral regimens of shorter duration Improved treatment adherence Implementation of community-based models of care Reduction in direct costs and indirect costs of patients Improved treatment outcomes Need for shorter, tolerable and effective regimen Hence modified BPaL regimen is designed to study the newer shorter oral in varying doses of Linezolid for pre XDR Tb patients and MDR TI/NR patients
Timeline
- Start
- 2021-10-07
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linezolid | Other / unclassified | 300 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | Oral |
| Background | Bedaquiline | Small molecule | 200 mg | Oral |
| Background | Pretomanid | Small molecule | 200 mg | Oral |