The following is a summary of “Exploration of a Potential DOOR Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs,” published in the March 2024 issue of Infectious Disease by Kinamon et al.
The desirability of outcome ranking (DOOR) method integrates trial data for a comprehensive risk-benefit assessment of therapeutic interventions, enhancing clinical analysis and design.
Researchers conducted a retrospective study to evaluate disease-specific DOOR endpoints for registrational trials for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
They examined the data of nearly 4,000 participants enrolled in six registrational trials for HABP/VABP submitted to the FDA between 2005 and 2022 to create a specific endpoint and estimate treatment advantages.
The results showed that DOOR distributions matched across trials. DOOR probability estimates ranged between (48.3%-52.9%) and were not statistically different. No significant differences in component analyses were found. However, More infectious complications and adverse events occurred in ventilated vs. non-ventilated patients, where the events were similar.
Investigators concluded that constructing and applying a potential DOOR endpoint for HABP/VABP trials, including syndrome-specific events, may enhance participant experience evaluation and trial design.
Source: academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae163/7634789
