Laboratory assessments
INFECTIOUS DISEASES, BLOOD, EVENT
Blood sampling to measure the concentrations of bedaquiline and linezolid will be conducted on months 2, 8 and 11 of treatment. Drug intake on the days for blood sampling will be performed by DOT and blood samples taken off prior to drug intake and 1-h post-drug intake. The blood samples will be placed in cooler boxes and transported to the laboratory on dry ice for samples from Lira Hospital and in a cooler box for samples from Mulago Hospital, processed and stored at −4 to −80 °C. Pharmacokinetic analysis will be performed at the Infectious Diseases Institution (IDI) translation laboratory. Quantification of the drug concentrations will be performed in batches using validated high-performance liquid chromatography (HPLC) and mass spectrometry at the Translation Laboratory of the Infectious Diseases Institute, Makerere University using MS.Sputum smears and cultures will be performed as part of routine care and testing conducted at the government reference laboratory.The study follow-up duration will be 24 months to cater for patients on both short- and long-term oral MDR-TB therapy. Treatment duration will be approximately 9 to 18 months: 9 months for participants that qualify for shorter MDR-TB/RR-TB treatment regimen and 18 months for those selected for the longer MDR-TB/RR-TB treatment regimen.To ensure data quality, study information is captured with an e-questionnaire in Redcap that has been designed to send real-time notifications for inputted variables that may be out of range. The tool also does not accept for the person collecting data (medical officer and or study nurse) to verify the tool, but is redirected to the study coordinator and Data Manager to do the final verification for correct and missing data. In addition, the entire study team was trained afore on the use of the study Redcap tool and on other study-related standard operating procedure manuals including the collection of blood specimens for continued reference. In the event of a protocol violation, retraining on study protocol and procedures will be conducted.