Trial reportPloS one2011
Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.
Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00144417 (TBTC Study 28), which is not on this map. Cited by 22 papers, 2 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.
TBTC Study 28: Evaluation of a Moxifloxacin-based, Isoniazid-sparing Regimen for Tuberculosis Treatment
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Meta-analysis of clinical studies supports the pharmacokinetic variability hypothesis for acquired drug resistance and failure of antituberculosis therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012Pooled it
- CDC/NIH Workshop. Tuberculosis biomarker and surrogate endpoint research roadmap.American journal of respiratory and critical care medicine · 2011Guideline
- Optimising pyrazinamide for the treatment of tuberculosis.The European respiratory journal · 2021Trial
- Nutritional markers and proteome in patients undergoing treatment for pulmonary tuberculosis differ by geographic region.PloS one · 2021Trial
- Predictors of delayed culture conversion among Ugandan patients.BMC infectious diseases · 2017Trial
- Tackling the unknowns of short-course rifapentine-based treatment for active tuberculosis: a decision analysis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2016Trial
- The pyrazinamide susceptibility breakpoint above which combination therapy fails.The Journal of antimicrobial chemotherapy · 2014Trial
- Clinically encountered growth phenotypes of tuberculosis-causing bacilli and theirFrontiers in cellular and infection microbiology · 2022Review
- A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens.BMC medicine · 2017Article
- Genetic Determinants of the Pharmacokinetic Variability of Rifampin in Malawian Adults with Pulmonary Tuberculosis.Antimicrobial agents and chemotherapy · 2017Article
- A Faropenem, Linezolid, and Moxifloxacin Regimen for Both Drug-Susceptible and Multidrug-Resistant Tuberculosis in Children: FLAME Path on the Milky Way.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Article
- Human ULK1 Variation and Susceptibility to Mycobacterium tuberculosis Infection.The Journal of infectious diseases · 2016Article
- Tuberculosis.Lancet (London, England) · 2016Review
- Pharmacodynamic Modeling of Bacillary Elimination Rates and Detection of Bacterial Lipid Bodies in Sputum to Predict and Understand Outcomes in Treatment of Pulmonary Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015Article
- Sputum culture conversion as a prognostic marker for end-of-treatment outcome in patients with multidrug-resistant tuberculosis: a secondary analysis of data from two observational cohort studies.The Lancet. Respiratory medicine · 2015Observational
- Five-year assessment of time of sputum smears conversion and outcome and risk factors of tuberculosis patients in central iran.Tuberculosis research and treatment · 2015Article
- Differences in EBA in the first two days of standard anti-tuberculosis treatment in different geographic regions.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2014Article
- Serum drug concentrations predictive of pulmonary tuberculosis outcomes.The Journal of infectious diseases · 2013Article
- Month 2 culture status and treatment duration as predictors of tuberculosis relapse risk in a meta-regression model.PloS one · 2013Review
- An evaluation of culture results during treatment for tuberculosis as surrogate endpoints for treatment failure and relapse.PloS one · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTuberculosis Trials Consortium Study 28, was a double blind, randomized, placebo-controlled, phase 2 clinical trial examining smear positive pulmonary Mycobacterium tuberculosis. Over the course of intensive phase therapy, patients from African sites had substantially delayed and lower rates of culture conversion to negative in liquid media compared to non-African patients. We explored potential explanations of this finding.
methodsIn TBTC Study 28, protocol-correct patients (n = 328) provided spot sputum specimens for M. tuberculosis culture in liquid media, at baseline and weeks 2, 4, 6 and 8 of study therapy. We compared sputum culture conversion for African and non-African patients stratified by four baseline measures of disease severity: AFB smear quantification, extent of disease on chest radiograph, cavity size and the number of days to detection of M. tuberculosis in liquid media using the Kaplan-Meier product-limit method. We evaluated specimen processing and culture procedures used at 29 study laboratories serving 27 sites.
resultsAfrican TB patients had more extensive disease at enrollment than non-African patients. However, African patients with the least disease by the 4 measures of disease severity had conversion rates on liquid media that were substantially lower than conversion rates in non-African patients with the greatest extent of disease. HIV infection, smoking and diabetes did not explain delayed conversion in Africa. Some inter-site variation in laboratory processing and culture procedures within accepted practice for clinical diagnostic laboratories was found.
conclusionsCompared with patients from non-African sites, African patients being treated for TB had delayed sputum culture conversion and lower sputum conversion rates in liquid media that were not explained by baseline severity of disease, HIV status, age, smoking, diabetes or race. Further investigation is warranted into whether modest variation in laboratory processes substantially influences the efficacy outcomes of phase 2 TB treatment trials or if other factors (e.g., nutrition, host response) are involved.
trial registrationClinicalTrials.gov NCT00144417.
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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.