Tuberculous Meningitis Clinical Trial
Official title:
Intensified Tuberculosis Treatment to Reduce the Mortality of HIV-infected and Uninfected Patients With Tuberculosis Meningitis: a Phase III Randomized Controlled Trial (Acronym: INTENSE-TBM)
INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults with or without HIV-infection in sub-Saharan Africa: - Intensified TBM treatment with high-dose rifampicin and linezolid, compared to WHO standard TBM treatment. - Aspirin, compared to not receiving aspirin. The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment.
Settings: Côte d'Ivoire, Madagascar, Uganda, South Africa. Follow-up: Participants will be followed up for 40 weeks. Sample size: 768 patients (192 in each arm). Primary analysis: We will use a Cox proportional hazard ratio model to compare intensified TB treatment with WHO standard TB treatment, and aspirin with placebo, adjusting for the initial stratification variables (trial country, HIV status, British Medical Research Council |BMRC] severity grade). The primary analysis will be conducted in the intention to treat population. Sub-studies: - The PK-PD sub-study will take place in the 4 participating countries, and involve 40 participants in total. - The Multi-Omics sub-study will only take place in South-Africa. It will involve 160 participants in this country. Participants in each sub-study will sign a specific informed consent. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01371916 -
Diagnosis of Tuberculous Meningitis by ESAT-6 in CSF
|
N/A | |
| Active, not recruiting |
NCT00433719 -
Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis
|
N/A | |
| Completed |
NCT02237365 -
A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis
|
Phase 2 | |
| Not yet recruiting |
NCT02588196 -
The Relationships Between Gene Polymorphisms of LTA4H and Dexamethasone Treatment for Tuberculous Meningitis
|
Phase 4 | |
| Completed |
NCT03092817 -
Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)
|
Phase 3 | |
| Recruiting |
NCT03787940 -
Optimizing Antituberculosis Therapy in Adults With Tuberculous Meningitis
|
N/A | |
| Not yet recruiting |
NCT05917340 -
Intensified Short Course Regimen for TBM in Adults
|
Phase 3 | |
| Completed |
NCT01802502 -
Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation
|
Phase 2 | |
| Recruiting |
NCT05636254 -
Diagnostic Accuracy of Imaging Findings in TBM/Spinal Tubercular Arachnoiditis and Correlation With Outcomes
|
||
| Recruiting |
NCT03898635 -
Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis
|
||
| Completed |
NCT05781646 -
Xpert MTB/RIF Assay for Diagnosis of Tuberculous Meningitis (TBM) in Maharaj Nakorn Chiang Mai Hospital
|
N/A | |
| Active, not recruiting |
NCT03100786 -
Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis
|
Phase 3 | |
| Recruiting |
NCT05383742 -
Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis
|
Phase 2 | |
| Completed |
NCT03226379 -
Driving Reduced AIDS-associated Meningo-encephalitis Mortality
|
N/A | |
| Recruiting |
NCT05590455 -
Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
|
Phase 2 | |
| Recruiting |
NCT04308928 -
Evaluation of New Biomarker-based Approaches for Improving the Diagnosis of Childhood Tuberculous Meningitis
|