Intensified Short Course Regimen for TBM in Adults

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

372

Participants

Timeline

Start Date

March 31, 2024

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Tuberculous Meningitis
Interventions
DRUG

High dose rifampicin (25mg/kg)

Given for 2 months

DRUG

Moxifloxacin 400mg

Given for 2 months

DRUG

Aspirin 150 mg

Given for 2 months

DRUG

Isoniazid

Given for 6 months

DRUG

Pyrazinamide

Given for 6 months

DRUG

Steroid

Tapering dose of dexamethasone or prednisolone upto 8 weeks

DRUG

Rifampicin

Standard dose for 4 months after the initial treatment with high dose

DRUG

HRZE

2 months

DRUG

HRE

7-10 months as per TB program guidelines

Trial Locations (1)

600031

ICMR- National Institute for Research in Tuberculosis, Chennai

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

All India Institute of Medical Sciences, Jodhpur

OTHER_GOV

collaborator

Christian Medical College, Vellore, India

OTHER

collaborator

Jawaharlal Institute of Postgraduate Medical Education & Research

OTHER_GOV

collaborator

North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences

OTHER_GOV

collaborator

Madras Medical College

OTHER_GOV

collaborator

Rural Development Trust Hospital

OTHER

lead

Indian Council of Medical Research

OTHER_GOV

NCT05917340 - Intensified Short Course Regimen for TBM in Adults | Biotech Hunter | Biotech Hunter