GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial

Phase 4

• Conditions: Ventilator-Associated Pneumonia (VAP)

• Registration Number: JPRN-UMIN000031933
• Lead Sponsor: Division of Trauma and Surgical Critical Care, Osaka General Medical Center

Brief Summary

Clinical response occurred in 79 patients (76.7%) in the Gram stain-guided group and 74 patients (71.8%) in the guideline-based group (risk difference, 0.05; 95% CI, -0.07 to 0.17; P < .001 for noninferiority). Reduced use of antipseudomonal agents (30.1%; 95% CI, 21.5%-39.9%; P < .001) and anti-MRSA agents (38.8%; 95% CI, 29.4%-48.9%; P < .001) was observed in the Gram stain-guided group vs guideline-based group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-28
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Patients will be excluded if they (1) have an allergy to study medications; (2) are pregnant; (3) have already been discharged from the ICU; (4) are diagnosed as having heart failure or atelectasis; (5) have been administered antibiotics for more than 24 hours when they meet the inclusion criteria; (6) are declined to provide full life support; or (7) are judged as inappropriate at the discretion of the study physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified