Infectious Diseases

DOOR analysis shows similar benefit–risk for omadacycline versus linezolid in ABSSSI trials

A DOOR endpoint integrating clinical response, infectious complications, serious adverse events, and mortality was applied to OASIS-1 and OASIS-2. The probability of a more desirable outcome with omadacycline versus linezolid was 50.6% (95% CI, 47.4%–53.7%) and 52.1% (95% CI, 49.2%–55.0%), respectively. Using SF-36v2 as a tiebreaker did not meaningfully change results. DOOR provided a complementary, patient-centered perspective on benefit–risk for ABSSSI trials. 1

Editorial: DOOR adds a different interpretive lens to infectious diseases trials

This editorial reviews recent post-hoc DOOR applications in infectious diseases randomized trials. DOOR emphasizes integrated patient-centered outcomes rather than single efficacy endpoints. The authors argue DOOR can change interpretation but requires prospective use and familiarity for correct application. 2

Externally validated popPK and model averaging support precision dalbavancin dosing for prolonged therapy

A two-compartment popPK model with eGFR and body weight was developed from 183 patients (406 concentrations) and externally validated in 30 patients (92 concentrations). Model averaging with two TDM measurements reduced rRMSE to 26.9%, improving predictive performance over a priori predictions. Simulations showed empirical repeat-dose regimens maintained target attainment ≥90% for 3–7 weeks, dependent on MIC and patient factors. Authors propose a sequential precision dosing workflow with Bayesian forecasting but state prospective validation is required. 3