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"Improving Tuberculous Meningitis Care: Testing the Safety and Effectiveness of Azathioprine in Managing Paradoxical Reactions - A Patient-Focused Study"

Safety and efficacy of azathioprine in the treatment of paradoxical reaction in patients with tuberculous meningitis: A randomized clinical trial - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060448
Enrollment
126
Registered
2023-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A170- Tuberculous meningitis

Interventions

Intervention1: AZATHIOPRINE: 2 months of daily oral isoniazid (5mg/kg of body weight, max 300mg) + rifampicin (10mg/kg, max 600mg)+ pyrazinamide (25mg/kg, max 2g/day) + i.m. streptomycin (20mg/kg, max
daily oral dose for following 4 weeks as 4, 3, 2, 1 mg/day on weeks 5, 6, 7, 8 respectively)for 2 months+Azathioprine(started at 1 mg/kg followed by uptitration to 2mg/kg at 1 month followup and then
daily oral dose for following 4 weeks as 4, 3, 2, 1 mg/day on weeks 5, 6, 7, 8 respectively) for 2 months

Sponsors

Department of Neurology King George Medical University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • All consecutive newly diagnosed patients of tuberculous meningitis, fulfilling the consensus diagnostic criteria as described by Marais et. Al. • Patients are categorized into definite, probable or possible tuberculous meningitis group on the basis of clinical, imaging and laboratory criteria. • DEFINITE CASES- either have acid fast bacilli in CSF or mycobacterium could be cultured from CSF or CSF is positive for mycobacterial nucleic acids by PCR. • PROBABLE CASES- they fulfill the clinical entry criteria plus a total diagnostic score of 10 or more points (when neuroimaging is absent) OR 12 or more points (when neuroimaging is present) plus excision of alternative diagnosis. • POSSIBLE CASES- clinical entry criteria plus a total diagnostic score of 6-9 points (when neuroimaging is not available) OR 6-11 points (when neuroimaging is available) along with the exclusion of alternative diagnosis.

Exclusion criteria

Exclusion criteria: 1. Patients with cryptococcal meningitis or any other cause for meningitis will be excluded. 2. Patients with having baseline deranged liver function tests, kidney function tests, pregnancy & lactation will be excluded. 3. Patients who do not give consent will be excluded. 4. Age 80 years 5. HIV Positive status

Design outcomes

Primary

MeasureTime frame
Paradoxical Reaction in Tuberculous meningitisTimepoint: Baseline, 1 month, 3 months & 6 months

Secondary

MeasureTime frame
Degree of disability (as per Modified Barthel Index) in patients with Tuberculous MeningitisTimepoint: 6 MONTHS;Mortality in patients with Tuberculous MeningitisTimepoint: 6 MONTHS

Countries

India

Contacts

Public ContactSaritesh Kumar Thakur

King George Medical University, Lucknow

drrajeshverma32@yahoo.com9335915823

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026