Intensified Short Course Regimen for TBM in Adults
Status:
Not yet recruiting
Trial end date:
2027-09-01
Target enrollment:
Participant gender:
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
Phase:
Phase 3
Details
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 Madras Medical College North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences Rural Development Trust Hospital