Media matters: Modeling the impact of solid media performance on tuberculosis trial sample size requirements

Details

• Alternative Title:
  Int J Tuberc Lung Dis
• Personal Author:
  Johnson, Matthew G. ; Stout, Jason E. ; Benator, Debra A. ; Whitworth, William C. ; Holland, David P.
• Description:
  Setting
  
  Two-month solid media culture conversion is a commonly used (if suboptimal) endpoint for phase 2 tuberculosis treatment trials.
  
  Objective and Design
  
  To model the effect of solid media performance characteristics (sensitivity and contamination rate) 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 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 tuberculosis clinical trial efficiency.
  
  
• Subjects:
  Antitubercular Agents Article Bacteriological Techniques Clinical Trials, Phase II As Topic Controlled Clinical Trials As Topic Culture Media Endpoint Determination Humans Predictive Value Of Tests Reproducibility Of Results Sample Size Time Factors Treatment Outcome Tuberculosis

  More +
• Source:
  Int J Tuberc Lung Dis. 20(5):600-604
• Pubmed ID:
  27084812
• Pubmed Central ID:
  PMC4960979
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHS/United States
• Volume:
  20
• Issue:
  5
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:62cb63739b3ab2f9e34cc583f4e7e103b9adc74dd46aea31c98c820be6df9ea9
• Download URL:
  https://stacks.cdc.gov/view/cdc/40497/cdc_40497_DS1.pdf
• File Type:
  [PDF - 257.92 KB ]