Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India

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

Conditions

• Pre-Extensively Drug-Resistant Pulmonary TB
• Treatment Intolerant Multidrug-Resistant Pulmonary TB
• Non-responsive Multidrug-Resistant Pulmonary TB

Interventions

DRUG

Linezolid

Participants will have a screening period of up to 14 days and will be randomized to one of the study arms in the ratio of 1:1:1, using an interactive web response system. Each participant will receive 26 weeks of treatment. If the participant's 16th-week sample remains culture positive, treatment will be extended up to 39 weeks. Participants will be followed for 48 weeks after the end of treatment

DRUG

Bedaquiline

Bedaquiline will be administered as four 100 mg tablets (400 mg) by mouth once a day for 2 weeks, followed by two 100 mg tablets (200 mg) by mouth three times a week for 24 weeks in all three arms

DRUG

Pretomanid

Pretomanid is administered as one tablet once a day for 26 weeks in all three arms

Sponsors & Collaborators

• International Union Against Tuberculosis and Lung Diseases

  collaborator OTHER

• Sarvodaya Charitable Trust Hospital, Ghatkopar, Mumbai

  collaborator UNKNOWN

• Shatabdi Centenary Hospital, Govandi, Mumbai

  collaborator UNKNOWN

• King George's Medical College and Hospital, Lucknow

  collaborator UNKNOWN

• SN Medical College, Agra

  collaborator UNKNOWN

• Govt Medical College & Hospital, Bhavnagar

  collaborator UNKNOWN

• Govt. Medical College & Hospital, Surat

  collaborator UNKNOWN

• National Institute for Tuberculosis and Respiratory Diseases, New Delhi

  collaborator UNKNOWN

• Rajan Babu Institute of Pulmonary Medicine and Tuberculosis, Delhi

  collaborator UNKNOWN

• Govt.Rajaji Medical college and hospital, Madurai

  collaborator UNKNOWN

• Tuberculosis Research Centre, India

  lead OTHER_GOV

Principal Investigators

• Padmapriyadarsini Chandrasekharan · Tuberculosis Research Centre, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-07

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• India

Study Locations