Plans for assessment and collection of outcomes {18a}
TTD
For this study, a data management group created a predefined data base. On a weekly basis, the sponsor receives data reports for review, including listings of blood results for the safety management of the participants. These listings help to identify and to act upon weaknesses in data capture but also quality. Further, this group will send queries to the responsible site in case data has been entered incorrectly or is missing. Several manuals (e.g. lab manual, manual of procedure for clinical assessment of the participants, including “red flags” for discussion with the sponsor medical expert, PK manual) exist to promote data quality. A site initiation visit will be conducted prior to study start to train assessors and a re-training will be conducted in case changes of the protocol occur.Further, time to detection (TTD) is a measurement of bacterial load in the liquid culture BD MGIT system. In order to reduce variability, we will collect two sputum samples per weekly visit and inoculate a MGIT culture from each sample.