Intensified Short Course Regimen for TBM in Adults

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

NCT Number	NCT05917340
Lead Sponsor	Indian Council of Medical Research Collaborators: All India Institute of Medical Sciences, Jodhpur, Christian Medical College, Vellore, India, Jawaharlal Institute of Postgraduate Medical Education & Research, North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences, Madras Medical College, Rural Development Trust Hospital
Conditions	Tuberculous Meningitis
Enrollment	372 participants
Start Date	2024-03
Primary Completion	2027-09 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2023-12-21