Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients

Active, not recruitingOBSERVATIONAL
Enrollment

550

Participants

Timeline

Start Date

March 15, 2022

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
Tuberculosis, Pulmonary
Interventions
DRUG

Isoniazid

Intensive Phase for 2 months and Continuation phase for 2 months dose: 75 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Rifampicin

Intensive Phase for 2 months and Continuation phase for 2 months dose: 150 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Pyrazinamide

Intensive Phase for 2 months only dose: 400 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Ethambutol

Intensive Phase for 2 months and Continuation phase for 2 months dose: 275 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Moxifloxacin

Intensive Phase for 2 months and Continuation phase for 2 months dose: 400 mg for 30 to 64 yrs AND 600 mg for 65 and above years of age.

Trial Locations (1)

600031

National Institute for Research in Tuberculosis, Chennai

All Listed Sponsors
collaborator

Indira Gandhi Government Medical College and Hospital (IGGMCH), Nagpur

UNKNOWN

collaborator

King George's Medical University, Lucknow

UNKNOWN

collaborator

Mahavir Hospital and Research Centre, Hyderabad

UNKNOWN

collaborator

Government Vellore Medical College and Hospital, Adukkamparai

UNKNOWN

collaborator

Lok Nayak hospital, New Delhi

UNKNOWN

lead

Tuberculosis Research Centre, India

OTHER_GOV