A Phase III multicentre, randomized, double-blind trial to evaluate the efficacy and safety of oral contezolid versus linezolid in adults with complicated skin and soft tissue infections—authors’ response

We appreciate the interest and comments of Rodgers and Wertheim1 regarding our article.2 We would like to respond to each query raised by Rodgers and Wertheim1 and where appropriate provide additional information. First, the treatment duration of this study was stated in the Study design section: 'Eligible patients were assigned randomly (1:1) to receive contezolid tablets 800 mg q12h or linezolid tablets 600 mg q12h with meals for 7–14 days using a centralized web-based interactive system.' The average treatment durations for patients receiving contezolid or linezolid were similar: 12.0 ± 2.7 or 11.8 ± 2.8 days for clinically cured patients and 11.2 ± 3.9 or 11.4 ± 3.4 days for the safety set (SS) population, respectively. These treatment duration data are consistent with the main conclusion of the study that contezolid and linezolid have similar efficacy in treating complicated skin and soft tissue infection. Furthermore, careful review of medical records pertaining to each patient admitted to the trial ensured that antimicrobial use prior to enrolment in this study and during the study period was carefully documented. Aztreonam was the only concomitant antibacterial drug allowed to be used during the treatment. If the patient received a non-protocol concomitant antibiotic the patient's outcome was automatically assigned an outcome of 'clinical failure'. In this study, no 'clinical cure' was achieved by a non-protocol drug.