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Early bactericidal activity studies for pulmonary tuberculosis: A systematic review of methodological aspects by Simon E. Koele; Patrick P.J. Phillips; Caryn M. Upton; Jakko van Ingen; Ulrika S.H. Simonsson; Andreas H. Diacon; Rob E. Aarnoutse; Elin M. Svensson is a Medicine article available to read on EtoBox.
What is Early bactericidal activity studies for pulmonary tuberculosis: A systematic review of methodological aspects about?
A milestone in the development of novel antituberculosis drugs is the demonstration of early bactericidal activity (EBA) in a phase IIa clinical trial. The significant variability in measurements of bacterial load complicates data analysis in these trials. A systematic review and evaluation of methods for determination of EBA in pulmonary tuberculosis studies was undertaken. Bacterial load quantification biomarkers, reporting intervals, calculation methods, statistical testing, and handling of negative culture results were extracted. In total, 79 studies were identified in which EBA was determined. Colony-forming units on solid culture media and/or time-to-positivity in liquid media were the biomarkers used most often, reported in 72 (91%) and 34 (43%) studies, respectively. Twenty-two different reporting intervals were presented, and 12 different calculation methods for EBA were identified. Statistical testing for a significant EBA compared with no change was performed in 54 (68%) studies, and between-group testing was performed in 32 (41%) studies. Negative culture result handling was discussed in 34 (43%) studies. Notable variation was found in the analysis methods and reporting
Who reads Early bactericidal activity studies for pulmonary tuberculosis: A systematic review of methodological aspects?
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- Author
- Simon E. Koele; Patrick P.J. Phillips; Caryn M. Upton; Jakko van Ingen; Ulrika S.H. Simonsson; Andreas H. Diacon; Rob E. Aarnoutse; Elin M. Svensson
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)