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Intensified Short Course Regimen for TBM in Adults
Sponsor: Indian Council of Medical Research
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
Conditions
Interventions
High dose rifampicin (25mg/kg)
Given for 2 months
Moxifloxacin 400mg
Given for 2 months
Aspirin 150 mg
Given for 2 months
Isoniazid
Given for 6 months
Pyrazinamide
Given for 6 months
Steroid
Tapering dose of dexamethasone or prednisolone upto 8 weeks
Rifampicin
Standard dose for 4 months after the initial treatment with high dose
HRZE
2 months
HRE
7-10 months as per TB program guidelines
Locations (1)
ICMR- National Institute for Research in Tuberculosis
Chennai, Tamil Nadu, India