Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Proposed Linezolid Dosing Strategies to Minimize Adverse Events for Treatment of Extensively Drug-Resistant Tuberculosis.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02333799 (A Phase 3 Open-label Trial Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Participants With Pulmonary Infection of Either XDR-TB or Treatment Intolerant / Non-responsive MDR-TB.), which is not on this map. Cited by 36 papers, 2 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.
A Phase 3 Open-label Trial Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Participants With Pulmonary Infection of Either XDR-TB or Treatment Intolerant / Non-responsive MDR-TB.
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Adverse Drug Reaction to Linezolid in Drug-Resistant Tuberculosis: A Systematic Review.Medical sciences (Basel, Switzerland) · 2025Pooled it
- Optimal dosing and duration of linezolid for the treatment of multidrug-resistant and rifampicin-resistant tuberculosis: an individual patient data meta-analysis.The European respiratory journal · 2025Pooled it
- Impact of High-Dose Rifampicin on Linezolid Pharmacokinetics in Tuberculous Meningitis.Open forum infectious diseases · 2026Trial
- 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
- Long term outcomes in drug resistant tuberculosis with Bedaquiline, Pretomanid and varying doses of Linezolid.The Journal of infection · 2025Trial
- Pharmacokinetic-pharmacodynamic modeling of tuberculosis time to positivity and colony-forming unit to assess the response to dose-ranging linezolid.Antimicrobial agents and chemotherapy · 2024Trial
- Linezolid Population Pharmacokinetic Model in Plasma and Cerebrospinal Fluid Among Patients With Tuberculosis Meningitis.The Journal of infectious diseases · 2024Trial
- High-dose linezolid during BPaL implementation for pre-extensively drug-resistant TB or failure/intolerance of rifampicin-resistant TB regimens.IJTLD open · 2026Article
- Therapeutic Drug Monitoring for Improving Tuberculosis Treatment Outcomes: A Scoping Review of Clinical Studies.Clinical pharmacokinetics · 2026Article
- Linezolid Related Adverse Effects in Different Populations: A Review.Current drug safety · 2026Review
- A Short-Course Regimen Containing Delamanid, Bedaquiline and Linezolid for the Treatment of Drug-Resistant Tuberculosis: A Retrospective Study from China.Infection and drug resistance · 2026Article
- Linezolid-induced peripheral neuropathy in a patient with multidrug-resistant pulmonary tuberculosis: a case report and comprehensive literature review.Neurologia croatica : glasilo Udruzenja neurologa Jugoslavije = official journal of Yugoslav Neurological Association · 2026Article
- Experience with Linezolid for the Treatment of Rifampin-Susceptible Tuberculosis in San Francisco.Open forum infectious diseases · 2025Article
- Risk Assessment of Linezolid-Associated Neurological Adverse Drug Reactions Based on the Food and Drug Administration Adverse Event Reporting System Database.Journal of multidisciplinary healthcare · 2025Article
- REVOLUTIONIZING TUBERCULOSIS REGIMEN DEVELOPMENT.Transactions of the American Clinical and Climatological Association · 2025Review
- Linezolid Pharmacokinetic-Anemia Modeling in Children With Rifampicin-Resistant Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Dose optimization of TBI-223 for enhanced therapeutic benefit compared to linezolid in antituberculosis regimen.Nature communications · 2024Article
- Management ofJournal of clinical tuberculosis and other mycobacterial diseases · 2024Review
- Predictive Modeling of Drug-Related Adverse Events with Real-World Data: A Case Study of Linezolid Hematologic Outcomes.Clinical pharmacology and therapeutics · 2024Article
- Multidrug-resistant tuberculosis.Nature reviews. Disease primers · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundWe evaluated Nix-TB trial data (NCT02333799, N = 109) to provide dosing recommendations to potentially minimize linezolid toxicity in patients with extensively drug-resistant tuberculosis. .
methodsA pharmacokinetic model and toxicodynamic models for peripheral neuropathy, hemoglobin, and platelets were developed. Simulations compared safety outcomes for daily linezolid of 1200 and 600 mg, with and without dose adjustments for toxicity. Severe neuropathy was based on symptom scores from the Brief Peripheral Neuropathy Screen. Severe anemia and thrombocytopenia were defined as ≥ grade 3 adverse events according to the NIAID Division of Microbiology and Infectious Disease Adult Toxicity table.
resultsPredicted concentration-time profiles were a major predictor in all toxicodynamic models. Simulations showed higher percentages of patients with severe neuropathy (median, 19%; 90% confidence interval [CI], 17%-22% vs 5%, 4%-7%) and severe anemia (15%, 12%-17% vs 1%, 0%-2%) between 1200 and 600 mg daily linezolid. No differences in severe thrombocytopenia were observed (median, <1% for both daily doses). Generally, neuropathy occurred after 3 to 6 months of treatment and, with protocol-specified management, reversed within 15 months after onset. Simulations indicated that a >10% decrease in hemoglobin level after 4 weeks of treatment would have maximum sensitivity (82%) and specificity (84%) for predicting severe anemia. Reducing the dose from 1200 to 600 mg triggered by this marker may prevent 60% (90% CI, 45%-72%) of severe anemia.
conclusionsSimple neuropathy symptom and hemoglobin monitoring may guide linezolid dosing to avoid toxicities, but prospective testing is needed to confirm the benefit-to-risk ratio.
Indexed as
Identifiers
What OpenQuestion holds
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.