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New treatment option for Tuberculous Meningitis
Official title Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis
ClinicalTrials.gov ID: NCT04145258
What this study is testing
What is Aspirin?
Aspirin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for tuberculous meningitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Age ≥ 15 years
- TBM defined as "definite", "probable" or "possible"
- 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...
- Probable TBM = total modified Marais score ≥12 when neuroimaging is available, or ≥10 when neuroimaging is not available (at least 2 points should...
You likely can't join if
- \> 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.
See the full eligibility criteria
- Age ≥ 15 years
- TBM defined as "definite", "probable" or "possible"
- 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.
- \> 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.
The study team makes the final eligibility decision.
Where it's taking place
- Abidjan, Côte d’Ivoire
- Antananarivo, Madagascar
- Fianarantsoa, Madagascar
- Toamasina, Madagascar
- Cape Town, South Africa
- Port Elizabeth, South Africa
- Mbarara, Uganda
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abidjan, Côte d’Ivoire; Antananarivo, Madagascar; Fianarantsoa, Madagascar; Toamasina, Madagascar; Cape Town, South Africa; Port Elizabeth, South Africa and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.