Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
A Phase 2A Trial of the Safety and Tolerability of Increased Dose Rifampicin and Adjunctive Linezolid, With or Without Aspirin, for Human Immunodeficiency Virus-Associated Tuberculous Meningitis: The LASER-TBM Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03927313 (Phase IIA Trial of the Safety and Tolerability of Increased Dose Rifampicin and Adjunctive Linezolid With or Without Aspirin, for HIV-associated Tuberculous Meningitis), which is not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Phase IIA Trial of the Safety and Tolerability of Increased Dose Rifampicin and Adjunctive Linezolid With or Without Aspirin, for HIV-associated Tuberculous Meningitis
Who cites it
34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Adjunctive linezolid in patients with tuberculous meningitis for the prevention of mortality or neurologic disability: a meta-analysis of randomized controlled trials.BMC infectious diseases · 2026Pooled it
- High dose of rifampicin in the treatment of tuberculous meningitis: a systematic review and meta-analysis of randomized controlled trials.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Pooled it
- A clinical practice guideline for tuberculous meningitis.The Lancet. Infectious diseases · 2026Guideline
- Safety of Triple-Dose Rifampin in Tuberculosis Treatment: A Systematic Review and Meta-Analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Pooled it
- Effects of aspirin on stroke and mortality in tubercular meningitis: a meta-analysis of randomized controlled trials.Frontiers in medicine · 2025Pooled it
- Pharmacokinetics of Dexamethasone in Tuberculous Meningitis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Intensified Treatment of Tuberculous Meningitis in Adults: A Systematic Review and Meta-analysis.Open forum infectious diseases · 2025Trial
- Population Pharmacokinetics of Rifampicin in Plasma and Cerebrospinal Fluid in Adults With Tuberculosis Meningitis.The Journal of infectious diseases · 2025Trial
- Population pharmacokinetics of pyrazinamide and isoniazid in plasma and cerebrospinal fluid from South African adults with tuberculous meningitis.Antimicrobial agents and chemotherapy · 2025Trial
- Safety and Tolerability of a Short Course of Linezolid for the Treatment of Predominantly Moderate to Severe Tuberculous Meningitis in Adults With Human Immunodeficiency Virus.The Journal of infectious diseases · 2025Trial
- Linezolid Population Pharmacokinetic Model in Plasma and Cerebrospinal Fluid Among Patients With Tuberculosis Meningitis.The Journal of infectious diseases · 2024Trial
- 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
- Proportional Odds or Win Probability as Methods for Assessing Ordinal Outcomes in Infectious Disease Clinical Trials.The Journal of infectious diseases · 2026Article
- Review
- Contribution of cytotoxic CD8 T cells, neutrophils and type 1 interferon signaling to hyperinflammation in HIV-associated TB meningitis.bioRxiv : the preprint server for biology · 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
- The Structure, Properties, and Clinical Utility of Contezolid for Antituberculosis: A Narrative Review.Infectious diseases and therapy · 2026Review
- Host-directed nanotherapy for the treatment and imaging of tuberculous meningitis.Theranostics · 2026Article
- Associations of recorded in-hospital linezolid and fluoroquinolone exposure with mortality and documented drug-induced liver injury in non-HIV tuberculous meningitis: a propensity score-weighted real-world cohort study.Frontiers in medicine · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
32 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundDrug regimens that include intensified antibiotics alongside effective anti-inflammatory therapies may improve outcomes in tuberculous meningitis (TBM). Safety data on their use in combination and in the context of human immunodeficiency virus (HIV) are needed to inform clinical trial design.
methodsWe conducted a phase 2, open-label, parallel-design, randomized, controlled trial to assess the safety of high-dose rifampicin, linezolid, and high-dose aspirin in HIV-associated TBM. Participants were randomized (1.4:1:1) to 3 treatment arms (1, standard of care [SOC]; 2, SOC + additional rifampicin [up to 35 mg/kg/d] + linezolid 1200 mg/d reducing after 28 days to 600 mg/d; 3, as per arm 2 + aspirin 1000 mg/d) for 56 days, when the primary outcome of adverse events of special interest (AESI) or death was assessed.
resultsA total of 52 participants with HIV-associated TBM were randomized; 59% had mild disease (British Medical Research Council (MRC) grade 1) vs 39% (grade 2) vs 2% (grade 3). AESI or death occurred in 10 of 16 (63%; arm 3) vs 4 of 14 (29%; arm 2) vs 6 of 20 (30%; arm 1; P = .083). The cumulative proportion of AESI or death (Kaplan-Meier) demonstrated worse outcomes in arm 3 vs arm 1 (P = .04); however, only 1 event in arm 3 was attributable to aspirin and was mild. There was no difference in efficacy (modified Rankin scale) between arms.
conclusionsHigh-dose rifampicin and adjunctive linezolid can safely be added to the standard of care in HIV-associated TBM. Larger studies are required to determine whether potential toxicity associated with these interventions, particularly high-dose aspirin, is outweighed by mortality or morbidity benefit. CLINICAL TRIALS REGISTRATION: NCT03927313.
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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.