se of thalidomide in complicated tubercular infection of brai
Phase 2
Recruiting
- Conditions
- Health Condition 1: A179- Tuberculosis of nervous system, unspecified
- Registration Number
- CTRI/2023/05/052417
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Possible, probable, or definite TBM as diagnosed by Marais et al criteria.
Patients already on standard ATT and steroid protocol for CNS TB who develop complications in the form of paradoxical worsening like opto-chiasmatic syndrome, spinal arachnoiditis, increase in tuberculomas, exudates or clinical worsening etc.
Patients willing to be followed up for at least 6 months for assessment.
Exclusion Criteria
1.Patients who are either HIV positive or immunocompromised due to some other disease.
2.Patients are on immunosuppressive drugs.
3.Patients who cannot undergo lumbar puncture or MRI examination.
4.Pregnant patients.
5.CSF gram stain or/and culture showing microorganisms other than acid fast bacilli.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome – Mortality at 6 months of intervention. <br/ ><br>Secondary outcome – <br/ ><br>•Clinical improvement <br/ ><br>oFunctional status – mRS scale. <br/ ><br>oVision – Grading of Visual Acuity <br/ ><br>•Radiological improvement <br/ ><br>oExudates – Present or absent. <br/ ><br>oTuberculomas – Number <br/ ><br>oInfarct – Present or absent. <br/ ><br>oHydrocephalus – Present or absent. <br/ ><br>•Presence of neurological deficit <br/ ><br>•Side effects of thalidomide <br/ ><br>Timepoint: Primary outcome – Mortality at 6 months of intervention. <br/ ><br>Secondary outcome – <br/ ><br>•Clinical improvement <br/ ><br>oFunctional status – mRS scale. <br/ ><br>oVision – Grading of Visual Acuity <br/ ><br>•Radiological improvement <br/ ><br>oExudates – Present or absent. <br/ ><br>oTuberculomas – Number <br/ ><br>oInfarct – Present or absent. <br/ ><br>oHydrocephalus – Present or absent. <br/ ><br>•Presence of neurological deficit <br/ ><br>•Side effects of thalidomide <br/ ><br>
- Secondary Outcome Measures
Name Time Method •Clinical improvement <br/ ><br>oFunctional status – mRS scale. <br/ ><br>oVision – Grading of Visual Acuity (Wall et al) (36) <br/ ><br>GradingVisual Acuity <br/ ><br>Mild vision loss6/9 – 6/12 <br/ ><br>Moderate Vision loss6/18 – 6/60 <br/ ><br>Severe Vision loss6/60 <br/ ><br>•Radiological improvement <br/ ><br>oExudates – Present or absent. <br/ ><br>oTuberculomas – Number <br/ ><br>oInfarct – Present or absent. <br/ ><br>oHydrocephalus – Present or absent. <br/ ><br>•Presence of neurological deficit <br/ ><br>•Side effects of thalidomide <br/ ><br>Timepoint: 1,2,3,4,5,6 months