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Could a drug cocktail slash deaths from TB of the brain?

NCT ID NCT04145258

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase III trial in sub-Saharan Africa tests whether giving higher doses of rifampicin plus linezolid, along with aspirin, can reduce deaths from tuberculous meningitis (TBM) in both HIV-positive and HIV-negative people. About 768 adolescents and adults will receive either the intensified treatment or standard WHO therapy, with or without aspirin. The goal is to see if these additions improve survival over the current standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-dose rifampicin, linezolid, and aspirin
What this could lead to
If successful, this could lead to a new standard treatment that lowers the death rate from tuberculous meningitis, a severe brain infection.
What could go wrong
This is a large Phase III trial, but the intensified drugs may cause more side effects, and the benefit over standard care is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 768 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Age ≥ 15 years 2. TBM defined as "definite", "probable" or "possible" 3. Signed Informed Consent * Definite TBM = at least one of the following criteria: acid-fast bacilli seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test. * Probable TBM = total modified Marais score ≥12 when neuroimaging is available, or ≥10 when neuroimaging is not available (at least 2 points should come from CSF or cerebral imaging criteria). * Possible TBM = total modified Marais 6-11 when neuroimaging is available, or 6-9 when neuroimaging is not available. Exclusion criteria: * \> 5 days of TB treatment * Renal failure (eGFR\<30 ml/min, CKD-EPI formula). * Neutrophil count \< 0.6 x 109/L. * Hemoglobin concentration \< 8 g/dL. * Total bilirubin \> 2.6 times the Upper Limit of Normal * Platelet count \< 50 x 109/L. * ALT \> 5 times the Upper Limit of Normal. * Clinical evidence of liver failure or decompensated cirrhosis. * For women: more than 17 weeks pregnancy or breastfeeding. * For patients without decrease level of consciousness (Glasgow Coma Scale = 15): Peripheral neuropathy scoring Grade 3 or above on the Brief Peripheral Neuropathy Score (BPNS). * Documented M. tuberculosis resistance to rifampicin. * Positive gram-stain, bacterial culture or cryptococcal antigen in the Cerebral Spinal Fluid. * Evidence of active bleeding (hemoptysis, gastrointestinal bleeding, hematuria, intracranial bleeding). * Inability to collect Cerebral Spinal Fluid, except for patients with confirmed tuberculosis (by rapid molecular test or culture) from another biological sample and clinical and/or CT scan evidence of meningitis. * Major surgery within the last two weeks prior to inclusion. * Ongoing chronic aspirin treatment (eg for cardiovascular risk). * Current use of drugs contraindicated with study drugs and that cannot be safely stopped (see Appendix 1: Drugs contra-indicated with study drugs). * In available history from patients: * Evidence of past intracranial bleeding. * Evidence of past of peptic ulceration. * Evidence of recent (\< 3 month) gastrointestinal bleeding. * Known hypersensitivity contraindicating the use of study drugs . * Evidence of porphyria. * Evidence of hyperuricemia or gout. * Any reason which at the discretion of the investigator would compromise safety and cooperation in the trial.

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Conditions

The condition(s) this trial relates to.

meningeal tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculous meningitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cocody University Hospital

    NOT_YET_RECRUITING

    Abidjan, Côte d’Ivoire

  • Dora Nginza Hospital

    RECRUITING

    Port Elizabeth, South Africa

  • Kayelitsha District Hospital

    RECRUITING

    Cape Town, South Africa

  • Livingstone and PE Central Hospitals

    RECRUITING

    Port Elizabeth, South Africa

  • Mbarara Regional Reference Hospital

    RECRUITING

    Mbarara, Uganda

  • Mitchells Plain Hospital

    RECRUITING

    Cape Town, South Africa

  • Morafeno University Hospital

    NOT_YET_RECRUITING

    Toamasina, Madagascar

  • New Somerset Hospital

    RECRUITING

    Cape Town, South Africa

  • Regional Reference Hospital of Kabale

    RECRUITING

    Mbarara, Uganda

  • Treichville University Hospital

    RECRUITING

    Abidjan, Côte d’Ivoire

  • University Hospital Joseph Raseta Befelatanana

    RECRUITING

    Antananarivo, Madagascar

  • University Hospital Tambohobe

    RECRUITING

    Fianarantsoa, Madagascar

  • Yopougon University Hospital

    NOT_YET_RECRUITING

    Abidjan, Côte d’Ivoire

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