NCT05917340

Intensified Short Course Regimen for TBM in Adults

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Indian Council of Medical Research · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tuberculous Meningitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2023-06-23
• Last updated: 2023-12-21

Locations

1 site across 1 country: India