A Phase 3 interventional study of Aspirin and Placebo of aspirin in Tuberculous Meningitis, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 13 sites in 4 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment
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:
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:
Participants in each sub-study will sign a specific informed consent.
31 studies on the registry are indexed under Tuberculosis, Meningeal; 9 are open to participants now.
This study's planned enrollment of 768 is above the median of 125 across 24 interventional studies indexed under Tuberculosis, Meningeal.
Browse Tuberculosis, Meningeal studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed
Exclusion criteria:
In available history from patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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 aspirin · Drug: WHO TBM treatment
* 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: Aspirin · Drug: WHO TBM treatment
* 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 aspirin · Drug: Intensified TBM treatment
* 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: Aspirin · Drug: Intensified TBM treatment
Two tablets of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
Two placebo tablets with the same appearance of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
2 months of (R-H-Z-E) + 7 months of (R-H)
Also known as: Standard WHO treatment for TB meningitis
2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid
Rate of all-cause death
Time frame: Up to 40 weeks
Rate of all-cause death
Time frame: Up to 8 weeks
Rate of all-cause death or loss to follow-up
Time frame: Up to 40 weeks
Rate of new central neurological event or aggravation of a central neurological event existing at baseline
Time frame: Up to 40 weeks
Rate of grade 3-4 adverse events (DAIDS adverse events grading table)
Time frame: Up to 40 weeks
Rate of serious adverse events
Time frame: Up to 40 weeks
Rate of solicited treatment related adverse events
Time frame: Up to 40 weeks
Percentage of patients with disability
Time frame: 40 weeks
M. tuberculosis culture conversion rate
Time frame: 1 week and 4 weeks
Time to culture positivity
Time frame: Up to 40 weeks
Time to first hospital discharge
Time frame: Up to 40 weeks
Cost-effectiveness incremental ratio of trial interventions
Time frame: Up to 40 weeks
Prevalence of resistance to anti-TB drugs among patients with positive culture at inclusion
Time frame: Up to 40 weeks
Subset of patients: In vitro bactericidal activity of anti-TBM treatment
Time frame: 1 week and 4 weeks
Subset of patients: Maximum Plasma Concentration [Cmax] of rifampicin and linezolid
Plasma Cmax, cerebrospinal fluid \[CSF\] Cmax, and plasma/CSF Cmax ratio
Time frame: 1 week and 4 weeks
Subset of patients: Minimum Plasma Concentration [Cmin] of rifampicin and linezolid
Plasma Cmin, cerebrospinal fluid \[CSF\] Cmin, and plasma/CSF Cmin ratio
Time frame: 1 week and 4 weeks
Subset of patients: Area Under the Curve [AUC] of rifampicin and linezolid
Plasma AUC, cerebrospinal fluid \[CSF\] AUC, and plasma/CSF AUC ratio
Time frame: 1 week and 4 weeks
Subset of patients: Time for maximal concentration [Tmax] of rifampicin and linezolid
Plasma Tmax, cerebrospinal fluid \[CSF\] Tmax, and plasma/CSF Tmax ratio
Time frame: 1 week and 4 weeks
Subset of patients: Half-life (t1/2) of rifampicin and linezolid
Plasma t1/2, cerebrospinal fluid \[CSF\] t1/2, and plasma/CSF t1/2 ratio
Time frame: 1 week and 4 weeks
HIV-infected participants: Rate of new AIDS-defining illnesses
Time frame: Up to 40 weeks
HIV-infected participants: Percentage of participants with virological success (plasma HIV-1 RNA <50 copies/ml)
Time frame: 28 weeks and 40 weeks
HIV-infected participants: CD4 count change from baseline
Time frame: 28 weeks and 40 weeks
HIV-infected participants, subset of patients: Maximum Plasma Concentration [Cmax] of of dolutegravir
Plasma Cmax, cerebrospinal fluid \[CSF\] Cmax, and plasma/CSF Cmax ratio
Time frame: 1 week and 4 weeks
HIV-infected participants, subset of patients: Minimum Plasma Concentration [Cmin] of dolutegravir
Plasma Cmin, cerebrospinal fluid \[CSF\] Cmin, and plasma/CSF Cmin ratio
Time frame: 1 week and 4 weeks
HIV-infected participants, subset of patients: Area Under the Curve [AUC] of dolutegravir
Plasma AUC, cerebrospinal fluid \[CSF\] AUC, and plasma /CSF AUC ratio
Time frame: 1 week and 4 weeks
HIV-infected participants, subset of patients: Time for maximal concentration [Tmax] of dolutegravir
Plasma Tmax, cerebrospinal fluid \[CSF\] Tmax, and plasma /CSF Tmax ratio
Time frame: 1 week and 4 weeks
HIV-infected participants, subset of patients: Half-life (t1/2) of dolutegravir
Plasma t1/2, cerebrospinal fluid \[CSF\] t1/2, and plasma/CSF t1/2 ratio
Time frame: 1 week and 4 weeks
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Studies of the drug tested here: Aspirin
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