biostudies-literatureUnknown76(11)Solans BPTB Alliance<h4>Background</h4>Safer, better, and shorter treatments for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) are an urgent global health need. The phase 3 clinical trial Nix-TB (NCT02333799) tested a 6-month treatment of MDR and XDR-TB consisting of high-dose linezolid, bedaquiline, and pretomanid (BPaL). In this study, we investigate the relationship between the pharmacokinetic characteristics of the drugs, patient characteristics and efficacy endpoints from Nix-TB.<h4>Methods</h4>Pharmacokinetic data were collected at weeks 2, 8, and 16. Efficacy endpoints including treatment outcomes, time to stable culture conversion, and longitudinal time to positivity in the mycobacterial growth indicator tube assay were each characterized using nonlinear mixed-effectClinical infectious diseases : an official publication of the Infectious Diseases Society of America1903-1910https://www.ebi.ac.uk/biostudies/studies/S-EPMC10249992biostudies-literatureAnalysis of Dynamic Efficacy Endpoints of the Nix-TB Trial.PMC10249992Solans BPSavic RMImperial MZOlugbosi MfalseAnalysis of Dynamic Efficacy Endpoints of the Nix-TB Trial.<h4>Background</h4>Safer, better, and shorter treatments for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) are an urgent global health need. The phase 3 clinical trial Nix-TB (NCT02333799) tested a 6-month treatment of MDR and XDR-TB consisting of high-dose linezolid, bedaquiline, and pretomanid (BPaL). In this study, we investigate the relationship between the pharmacokinetic characteristics of the drugs, patient characteristics and efficacy endpoints from Nix-TB.<h4>Methods</h4>Pharmacokinetic data were collected at weeks 2, 8, and 16. Efficacy endpoints including treatment outcomes, time to stable culture conversion, and longitudinal time to positivity in the mycobacterial growth indicator tube assay were each characterized using nonlinear mixed-effect2023-01-01T00:00:00Z2023 Jun2026-05-28T22:12:58.034Z2024-11-08T21:09:38.235ZS-EPMC102499923680483410.1093/cid/ciad051