A Comparative study of different treatment regimes for brain tuberculosis

Phase 1

Recruiting

• Conditions: Meningeal tuberculoma,

• Registration Number: CTRI/2019/05/019222
• Lead Sponsor: Department of Science and Technology

Brief Summary

1. This is a prospective randomised clinical study comprising of 25 patients in each arm using random table method:Group A- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 2 drugs (INH, Rifampicin) in the maintenance phase. Group B- 5-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol and Moxifloxacin in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin and Moxifloxacin in the maintenance phase. Group C- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin, Pyrazinamide) in the maintenance phase. The aims and objectives are to compare the effect of the 3 regimens in the resolution of  Brain Tuberculomas, to check if resolution of Tuberculomas begins faster with 5 drug regime or intensification of the 1st line drugs, to check the time taken for complete resolution of Tuberculomas in the three groups, to assess the post resolution residual damage to the brain between the three groups and to correlate the clinical features, cytokines level and neuroimaging. The recruitment phase of this study is for 18 months followed by 18 months of follow up with visits every 3 months with clinical exams and serial MRI imaging at each visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-27
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Clinically and radiologically suspected cases of CNS tuberculoma.

Exclusion Criteria

<18yrs, pregnant, HIV positive,refusal to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in size/disappearance of Tuberculoma	3 months, 6 months, 12 months, 18 months

Secondary Outcome Measures

Name	Time	Method
Improvement in clinical parameters,symptoms and signs like headache,focal deficits and reduction in disability scores.

Trial Locations

Locations (1)

NIMHANS; 🇮🇳 Bangalore, KARNATAKA, India

NIMHANS

🇮🇳Bangalore, KARNATAKA, India

Dr Nalini A

Principal investigator

9632505634

atchayaramnalini@yahoo.co.in