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Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis

NCT04145258 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 768

Last updated 2024-01-22

No results posted yet for this study

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.

Conditions

  • Tuberculous Meningitis

Interventions

DRUG

Aspirin

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

DRUG

Placebo of aspirin

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

DRUG

WHO TBM treatment

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

DRUG

Intensified TBM treatment

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

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Fabrice Bonnet, M.D., Ph.D. · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-07
Primary Completion
2025-09-30
Completion
2026-04-30

Countries

  • Côte d’Ivoire
  • Madagascar
  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145258 on ClinicalTrials.gov