Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa
| العنوان: | Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa |
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| المؤلفون: | Grace Muzanye, Lois Diem, Stefan V. Goldberg, Lorna Bozeman, Beverly Metchock, Kenneth C. Jost, William R. Mac Kenzie, John L. Johnson, Kathleen D. Eisenach, Denise Dunbar, Susan E. Dorman, Charles M. Heilig |
| المصدر: | PLoS ONE, Vol 6, Iss 4, p e18358 (2011) PLoS ONE |
| بيانات النشر: | Public Library of Science (PLoS), 2011. |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Bacterial Diseases, Research Validity, Time Factors, Epidemiology, Applied Microbiology, Cell Culture Techniques, lcsh:Medicine, HIV Infections, Disease, law.invention, Clinical trials, Randomized controlled trial, law, Culture conversion, lcsh:Science, Multidisciplinary, medicine.diagnostic_test, biology, Geography, Research Assessment, Phase II, Clinical Laboratory Sciences, Infectious Diseases, Medical Microbiology, Medicine, Public Health, medicine.symptom, Research Article, medicine.medical_specialty, Tuberculosis, Science Policy, Microbiology, Sputum culture, Mycobacterium, Specimen Handling, Mycobacterium tuberculosis, Diagnostic Medicine, Internal medicine, medicine, Humans, Biology, Probability, business.industry, Racial Groups, lcsh:R, Sputum, Tropical Diseases (Non-Neglected), biology.organism_classification, medicine.disease, Surgery, Culture Media, Radiography, Africa, lcsh:Q, Chest radiograph, business, Clinical research design |
| الوصف: | Background: Tuberculosis 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. Methods: In 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 KaplanMeier product-limit method. We evaluated specimen processing and culture procedures used at 29 study laboratories serving 27 sites. Results: African 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. Conclusions: Compared 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 Registration: ClinicalTrials.gov NCT00144417 |
| اللغة: | English |
| تدمد: | 1932-6203 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ff7bedad0c7e889291c30c17e5d3dd23 http://europepmc.org/articles/PMC3073969?pdf=render |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....ff7bedad0c7e889291c30c17e5d3dd23 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19326203 |
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