CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 768 target
Drug / intervention
Aspirin +3 moredrug
Likely dose
Aspirin 100 mgfrom record
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NCT04145258Phase 3RecruitingOn Track
Long Recruiting
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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)

ANRS, Emerging Infectious Diseases·interventional·Posted Oct 30, 2019·Updated Jun 24, 2026

In Brief

A Phase 3 clinical trial evaluating Aspirin, Placebo of aspirin, and 2 other interventions for Tuberculous Meningitis. Currently recruiting, targeting 768 participants across 13 sites in 4 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculous Meningitis
CountriesCôte d’Ivoire, Madagascar, South Africa, Uganda
CollaboratorsEuropean Union, European and Developing Countries Clinical Trials Partnership (EDCTP)

Timeline

Phase 3Recruiting
2020202120222023202420252026
First PostedOct 30, 2019
Enrollment StartFeb 7, 2021
Primary CompletionSep 23, 2026
Study CompletionSep 26, 2026
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 6.7 years agoPrimary completion in 3 months

Arms & Interventions

WHO TBM treatment + placeboother

* Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + placebo of aspirin * W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Drug: Placebo of aspirinDrug: WHO TBM treatment
WHO TBM treatment + aspirinother

* Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + aspirin 200 mg/d * W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Drug: AspirinDrug: WHO TBM treatment
Intensified TBM treatment + placeboother

* Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg/kg/d) + high dose linezolid (1200 mg/d from D-0 to end of W-4, then 600 mg/d from W-5 to W-8) + isoniazid 5 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + placebo of aspirin * W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Drug: Placebo of aspirinDrug: Intensified TBM treatment
Intensified TBM treatment + aspirinother

* Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg/kg/d) + high dose linezolid (1200 mg/d from D-0 to end of W-4, then 600 mg/d from W-5 to W-8) + isoniazid 5 mg/kg/d + ethambutol 20 mg/kg/d + pyrazinamide 30 mg/kg/d + aspirin 200 mg/d * W-9 to W-40: isoniazid 5 mg/kg/d + rifampicin 10 mg/kg/d.

Drug: AspirinDrug: Intensified TBM treatment

Interventions

Aspirindrug

Two tablets of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)

Placebo of aspirindrug

Two placebo tablets with the same appearance of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)

WHO TBM treatmentdrug

2 months of (R-H-Z-E) + 7 months of (R-H)

Intensified TBM treatmentdrug

2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid