Objective:
To evaluate the overall outcomes of omadacycline and linezolid in treating acute bacterial skin and skin structure infections using the DOOR framework.
Approach:
- Study Design: Retrospective analysis of two randomized trials (OASIS-1 and OASIS-2) involving 1,347 participants.
- DOOR Framework: Applied a patient-centered desirability of outcome ranking (DOOR) to assess treatment benefits and harms.
- Patient Population: Included 627 patients from OASIS-1 and 720 from OASIS-2, focusing on survival and undesirable events.
- Outcome Assessment: Patients ranked based on survival and events: absence of clinical response, infectious complications, and nonfatal serious adverse events.
Key Findings:
- About 80% of patients in each trial had the most desirable DOOR outcome.
- The DOOR probability for omadacycline was 50.6% in OASIS-1 (95% CI, 47.4%-53.7%) and 52.1% in OASIS-2 (95% CI, 49.2%-55.0%), indicating no significant difference between treatments.
- In OASIS-2, quality-of-life scores slightly favored omadacycline but were not statistically significant.
- No significant treatment differences were found for individual DOOR components.
Interpretation:
The DOOR framework provides a comprehensive understanding of treatment benefits and risks, showing similar outcomes for omadacycline and linezolid.
Limitations:
- Data derived from only two trials funded by the same pharmaceutical company.
- Serious adverse events and deaths were rare, complicating treatment distinction.
- Post hoc review of infectious complications relied on coded data, potentially missing details.
Conclusion:
The DOOR framework is feasible and should be incorporated into future ABSSSI trials.
Sources:
This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.
