Aspirin and Clopidogrel in patients with Tubercular meningitis

Phase 3

• Conditions: Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere

• Registration Number: CTRI/2019/08/020488
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age 18 years old or older

2.Willing to participate in the study by signing informed consent

3.Clinically diagnosed as TB meningitis by standard criteria using clinical, CSF and radiological findings using modified Ahujaâ??s criteria

Exclusion Criteria

1. Failure to perform lumbar puncture

2. Current use of antiplatelet agents

3. Contraindication for the use of aspirin or clopidogrel

4. Known hypersensitivity to aspirin or clopidogrel

5. Active bleeding

6. HIV positivity

7. Disseminated tuberculosis other than pulmonary TB.

8. Proven MDR, XDR TB.

9. Confirmed meningitis other than TB

10. Already on treatment for tuberculosis for more than 15 days prior to current admission

11. Pregnant or lactating females

12. Hepatic insufficiency (ALT >5x upper normal limit)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Outcome Measure: <br/ ><br> <br/ ><br>1. Occurrence of cerebral infraction on MRI Brain and / or clinical evidence of stroke at 1 and 3 months of follow up. <br/ ><br> <br/ ><br>Primary Safety Outcome Measure: <br/ ><br> <br/ ><br>1. Any major or minor bleeding <br/ ><br>2. Any hematemesis or intracerebral haemorrhage(parenchymal, subarachnoid, subdural, extradural) <br/ ><br> <br/ ><br>Timepoint: 1, 3 months.

Secondary Outcome Measures

Name	Time	Method
1. Mortality at 1and 3 months of follow up. <br/ ><br>2. Morbidity as assessed using modified Rankin score (mRS) at 3 ,6 months of follow up. <br/ ><br>3. Difference between aspirin and clopidogrel in the occurrence of cerebral infraction or stroke, mortality and functional outcome. <br/ ><br>4. Longterm follow up data upto one year shall be observed for all possible patients for mortality and morbidity on follow up. <br/ ><br>Timepoint: 1, 3, 6 months