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Intensified Short Course Regimen for TBM in Adults

Study acronym: INSHORT
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Oct 2026 to Sep 2027
    • Start date: Oct 2023 to Mar 2024
    • Study completion date: Jan 2027 to Sep 2027
    v3
  2. Minor Enrollment target: 380 to 372
    • Study arms: 2 to 3
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
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
(from sponsor)
Tuberculous Meningitis
Related terms Tuberculosis, Meningeal
Enrollment 372 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov