ReviewPloS one2013
Month 2 culture status and treatment duration as predictors of tuberculosis relapse risk in a meta-regression model.
Review in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04930744 (A Prospective, Randomized Open-Label Phase II Study of the Safety and Tolerability of Metformin in Combination With Standard Antimicrobial Treatment of Pulmonary Tuberculosis in People Co-infected With HIV), which is not on this map. Cited by 47 papers, 6 of them syntheses that pooled it.
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.
A Prospective, Randomized Open-Label Phase II Study of the Safety and Tolerability of Metformin in Combination With Standard Antimicrobial Treatment of Pulmonary Tuberculosis in People Co-infected With HIV
Who cites it
47 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Model-Based Meta-Analysis of Relapsing Mouse Model Studies from the Critical Path to Tuberculosis Drug Regimens Initiative Database.Antimicrobial agents and chemotherapy · 2022Pooled it
- The effects of anti-inflammatory agents as host-directed adjunct treatment of tuberculosis in humans: a systematic review and meta-analysis.Respiratory research · 2020Pooled it
- Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Pooled it
- Moxifloxacin and gatifloxacin for initial therapy of tuberculosis: a meta-analysis of randomized clinical trials.Emerging microbes & infections · 2016Pooled it
- Pooled it
- Month 2 culture status and treatment duration as predictors of recurrence in pulmonary tuberculosis: model validation and update.PloS one · 2015Pooled it
- Risk-stratified treatment for drug-susceptible pulmonary tuberculosis.Nature communications · 2024Trial
- Adjunctive host-directed therapies for pulmonary tuberculosis: a prospective, open-label, phase 2, randomised controlled trial.The Lancet. Respiratory medicine · 2021Trial
- Evaluation of six months sputum culture conversion as a surrogate endpoint in a multidrug resistant-tuberculosis trial.PloS one · 2018Trial
- Trial
- Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials.BMC medicine · 2016Trial
- The pyrazinamide susceptibility breakpoint above which combination therapy fails.The Journal of antimicrobial chemotherapy · 2014Trial
- Factors associated with extended treatment duration in patients with drug-susceptible pulmonary tuberculosis: a prospective multicentre cohort study in South Korea.BMC infectious diseases · 2026Article
- The PATHFAST TB LAM Ag assay: a validated protocol for quantitative tuberculosis treatment monitoring.Frontiers in antibiotics · 2026Article
- Vitamin C and Tuberculosis: Examining the Relationship Between Antioxidant Defense and Disease Severity-Preliminary Findings from a Southwestern Romanian Study.Journal of clinical medicine · 2024Article
- Baseline and end-of-treatment host serum biomarkers predict relapse in adults with pulmonary tuberculosis.The Journal of infection · 2024Article
- Therapeutic developments for tuberculosis and nontuberculous mycobacterial lung disease.Nature reviews. Drug discovery · 2024Review
- Longitudinal analysis of host protein serum signatures of treatment and recovery in pulmonary tuberculosis.PloS one · 2024Article
- Tuberculosis Severity Predictive Model Using Mtb Variants and Serum Biomarkers in a Colombian Cohort of APTB Patients.Biomedicines · 2023Article
- Advancing personalized medicine for tuberculosis through the application of immune profiling.Frontiers in cellular and infection microbiology · 2023Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNew drugs and regimens with the potential to transform tuberculosis treatment are presently in early stage clinical trials.
objectiveThe goal of the present study was to infer the required duration of these treatments.
methodA meta-regression model was developed to predict relapse risk using treatment duration and month 2 sputum culture positive rate as predictors, based on published historical data from 24 studies describing 58 regimens in 7793 patients. Regimens in which rifampin was administered for the first 2 months but not subsequently were excluded. The model treated study as a random effect.
resultsThe model predicted that new regimens of 4 or 5 months duration with rates of culture positivity after 2 months of 1% or 3%, would yield relapse rates of 4.0% or 4.1%, respectively. In both cases, the upper limit of the 2-sided 80% prediction interval for relapse for a hypothetical trial with 680 subjects per arm was <10%. Analysis using this model of published month 2 data for moxifloxacin-containing regimens indicated they would result in relapse rates similar to standard therapy only if administered for ≥5 months.
conclusionsThis model is proposed to inform the required duration of treatment of new TB regimens, potentially hastening their accelerated approval by several years.
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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.