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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

October 7, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Pre-Extensively Drug-Resistant Pulmonary TBTreatment Intolerant Multidrug-Resistant Pulmonary TBNon-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

Trial Locations (1)

Unknown

S N Medical College, Agra

All Listed Sponsors
collaborator

International Union Against Tuberculosis and Lung Diseases

OTHER

collaborator

Sarvodaya Charitable Trust Hospital, Ghatkopar, Mumbai

UNKNOWN

collaborator

Shatabdi Centenary Hospital, Govandi, Mumbai

UNKNOWN

collaborator

King George's Medical College and Hospital, Lucknow

UNKNOWN

collaborator

SN Medical College, Agra

UNKNOWN

collaborator

Govt Medical College & Hospital, Bhavnagar

UNKNOWN

collaborator

Govt. Medical College & Hospital, Surat

UNKNOWN

collaborator

National Institute for Tuberculosis and Respiratory Diseases, New Delhi

UNKNOWN

collaborator

Rajan Babu Institute of Pulmonary Medicine and Tuberculosis, Delhi

UNKNOWN

collaborator

Govt.Rajaji Medical college and hospital, Madurai

UNKNOWN

lead

Tuberculosis Research Centre, India

OTHER_GOV