ArticleTrials2022
Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04145258 (Intensified Tuberculosis Treatment to Reduce the Mortality of HIV-infected and Uninfected Patients With Tuberculosis Meningitis), which is not on this map. Cited by 26 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
26 citing papers in PubMed, 37 citations in OpenAlex.
- Ischaemia in tuberculous meningitis: update on pathophysiology, clinical predictors and management.Current opinion in infectious diseases · 2026Review
- Assessing transporter-mediated rifampin-linezolid interaction using physiologically-based pharmacokinetic modelling.British journal of clinical pharmacology · 2026Article
- Central nervous system tuberculosis: characteristics, risks, and outcomes in California adults, 2010-2022.Journal of clinical tuberculosis and other mycobacterial diseases · 2026Article
- Drug-Resistant Tuberculous Meningitis (DR-TBM) in a Low-Incidence Setting: Two Cases and an Evidence Review Highlighting Key Advances and Knowledge Gaps in Clinical Management.Open forum infectious diseases · 2026Article
- New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025Review
- Brain Imaging and Whole Blood Targeted Transcriptomic Analyses to Characterize Cerebral Infarctions in Children With Tuberculous Meningitis.The Journal of infectious diseases · 2025Article
- Central nervous system TB: a retrospective review of management.IJTLD open · 2025Article
- Predictors of Tuberculous Meningitis Mortality Among Persons with HIV in Mozambique.Tropical medicine and infectious disease · 2025Article
- Recent advancements in drug development for pulmonary tuberculosis.Archives of microbiology · 2025Review
- Paradoxical Reactions of Central Nervous System Tuberculosis: Report of Three Immunocompetent Cases.Case reports in infectious diseases · 2025Article
- Advances in the Treatment and Clinical Management Strategies of Tuberculous Meningitis.International journal of general medicine · 2025Review
- Progress of anti-tuberculosis drug targets and novel therapeutic strategies.Frontiers in microbiology · 2025Review
- Repurposed Drugs and Plant-Derived Natural Products as Potential Host-Directed Therapeutic Candidates for Tuberculosis.Biomolecules · 2024Review
- Dynamic PET reveals compartmentalized brain and lung tissue antibiotic exposures of tuberculosis drugs.Nature communications · 2024Observational
- Rifabutin central nervous system concentrations in a rabbit model of tuberculous meningitis.Antimicrobial agents and chemotherapy · 2024Article
- A retrospective study on intracranial mixed infection with tuberculous meningitis in Shenzhen, China.Microbiology spectrum · 2024Article
- Article
- A teenage girl with altered mental status and paraparesis.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Article
- Dynamic PET Reveals Compartmentalized Brain and Lung Tissue Antibiotic Exposures.Research square · 2024Article
- Linezolid does not improve bactericidal activity of rifampin-containing first-line regimens in animal models of TB meningitis.International journal of antimicrobial agents · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 11 institutions in 8 countries.
Funding
Abstract
backgroundTuberculous meningitis (TBM) is the most lethal and disabling form of tuberculosis (TB), particularly in sub-Saharan Africa. Current anti-TB treatment is poorly effective since TBM mortality reaches 40% in HIV-negative patients and up to 70% in HIV-co-infected patients. To reduce TBM-induced morbidity and mortality, the INTENSE-TBM trial evaluates two interventions in both HIV-infected and uninfected patients: an anti-TB treatment intensification using oral high-dose rifampicin (35 mg/kg daily) and linezolid (1200 mg daily and then 600 mg daily) during the first 8 weeks of the anti-TB treatment and the use of adjunctive aspirin (200 mg daily).
methodsThis is a randomized controlled, phase III, multicenter, 2 × 2 factorial plan superiority trial. The trial has four arms, combining the two experimental treatments (intensified TBM regimen and aspirin) with the two reference treatments (WHO standard TB treatment and placebo), and is open-label for anti-TB treatment and double-blind placebo-controlled for aspirin treatment. This trial is conducted in adults or adolescents of age ≥15 years with TBM defined as "definite," "probable," or "possible" using Tuberculosis Meningitis International Research Consortium criteria, in four African countries: Ivory Coast, Madagascar, Uganda, and South Africa. The primary outcome is all-cause death between inclusion and week 40. DISCUSSION: The INTENSE-TBM trial represents a key opportunity to enhance TBM treatment with widely available existing drugs notably in high-incidence settings of both TB and HIV. The trial design is pragmatic and the results will permit early and effective applications in TBM patient care, in both HIV and TB high-incidence countries.
trial registrationClinicalTrials.gov NCT04145258. Registered on October 30, 2019.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.