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NOT YET RECRUITING
NCT05917340
PHASE3

Intensified Short Course Regimen for TBM in Adults

Sponsor: Indian Council of Medical Research

View on ClinicalTrials.gov

Summary

Tuberculous meningitis (TBM) is the most lethal form of extra pulmonary tuberculosis. This devastating disease kills almost a third of its sufferers and disables a significant proportion of the survivors. TBM poses one of the most difficult diagnostic and therapeutic challenges in modern clinical practice. High-quality robust clinical trials have made a considerable contribution to the treatment of pulmonary tuberculosis in the last four decades. However, evidence from such clinical trials is lacking in TBM and the treatment remains uncertain. There is a significant variation in the choice, dose and duration of drugs between countries, institutions and clinicians. Investigators propose a multi-centric open-label clinical trial to assess the efficacy of short-course anti-TB drugs with high dose rifampicin, and moxifloxacin along with conventional anti-TB drugs and adjuvant therapy with aspirin and corticosteroids. Controls will receive standard treatment as per national guidelines for TBM. The investigators also aim to assess the safety and tolerability of high-dose Rifampicin and Moxifloxacin and the Pharmacodynamics and Pharmacokinetics parameters of ATT (Rifampicin, INH, Moxifloxacin and Pyrazinamide) in CSF between the two groups

Official title: Comparative Evaluation of Intensified Short Course Regimen and Standard Regimen for Adults TB Meningitis : an Open-label Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2024-03

Completion Date

2027-09

Last Updated

2023-12-21

Healthy Volunteers

No

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

Locations (1)

ICMR- National Institute for Research in Tuberculosis

Chennai, Tamil Nadu, India