Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements
OBJECTIVE AND DESIGN: To model the effect of the performance characteristics (sensitivity and contamination rate) of solid medium on required sample size for a two-arm clinical trial with 85% true (gold standard) culture conversion in the control and 95% in the experimental arm.
RESULTS: Increasing sensitivity and decreasing contamination reduced the sample size from 239 subjects/arm (60% sensitivity, 30% contamination) to 138 subjects/arm (95% sensitivity, 1% contamination).
CONCLUSION: Optimizing solid medium has significant potential to reduce sample size and increase the efficiency of tuberculosis clinical trials.
Keywords: Mycobacterium tuberculosis; clinical trials; mathematical modeling; microbiology
Document Type: Research Article
Affiliations: 1: Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA 2: Infectious Diseases Section, Veterans Affairs Medical Center and the George Washington University Medical Center, Washington DC, USA 3: Clinical Research Branch, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, USA 4: Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA; Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA
Publication date: 01 May 2016
The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.
The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.
- Editorial Board
- Information for Authors
- Subscribe to this Title
- International Journal of Tuberculosis and Lung Disease
- Public Health Action
- Ingenta Connect is not responsible for the content or availability of external websites
- Access Key
- Free content
- Partial Free content
- New content
- Open access content
- Partial Open access content
- Subscribed content
- Partial Subscribed content
- Free trial content