Triplicate Sputum Cultures for Efficacy Evaluation of Novel Antituberculosis Regimens

• Published in: American journal of respiratory and critical care medicine Vol. 196; no. 12; pp. 1612 - 1615
• Main Authors: Diacon, Andreas H, van Brakel, Elana, Lounis, Nacer, Meyvisch, Paul, Van Baelen, Ben, De Marez, Tine, Jenkins, Eilidh, Dannemann, Brian
• Format: Journal Article
• Language: English
• Published: United States American Thoracic Society 15.12.2017
• Subjects: Adult; Aged; Aged, 80 and over; Antitubercular Agents - therapeutic use; Correspondence; Double-Blind Method; Drug Resistance, Multiple; Female; Humans; Laboratories; Male; Middle Aged; Multidrug resistant organisms; Mycobacterium tuberculosis - drug effects; Patients; R&D; Research & development; Sputum - microbiology; Tuberculosis; Tuberculosis, Pulmonary - diagnosis; Tuberculosis, Pulmonary - drug therapy; United Kingdom > UK; United States > US; New Jersey
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/rccm.201704-0796LE

[...]we did not examine grades of positivity within triplicates but consider it beyond the scope of this work. [...]collection of triplicate instead of single sputa and deriving an aggregate score increases the sensitivity for efficacy determination in studies of antituberculosis regimens by increasing the proportion of positive and negative visits and reducing the proportion of uninformative visits. Triplicate sputum sampling is relatively little extra work and increases the proportion of evaluable patients, thereby reducing the size, duration, and cost of studies, which is an important consideration in planning Mycobacterium tuberculosis clinical trials in resource-limited settings. Author Contributions: A.H.D. and E.v.B. initiated this analysis, participated in recruiting significant numbers of patients to the C208 trial, and reported data for those patients; T.D.M. had a significant involvement in the study conception and design; N.L., P.M., B.V.B., E.J., and B.D. all had significant involvement in the data analyses; all authors were involved in the development of the manuscript, interpretation of data, have read and approved the final version, and have met the criteria for authorship as established by the International Committee of Medical Journal Editors.