6/28/23, 10:56 PM GRACE-VAP Pathway Feedback Search Clinical Topics Home Studies GRACE VAP GRACE VAP Disease Ventilator-associated pneumonia Trial question Is Gram stain-guided antibiotic therapy noninferior to guideline-based antibiotic therapy in patients with ventilator-associated pneumonia? Study design Multi-center Open label RCT Population Characteristics of study participants 32.0% female N = 206 68.0% male 206 patients (65 female, 141 male) Inclusion criteria: patients with ventilator-associated pneumonia in the ICU Key exclusion criteria: known allergy to study medications; discharge from ICU; HF; atelectasis; receipt of antibiotics for > 24 hours; withdrawal or withholding of life support; COVID-19 infection Interventions N=103 Gram stain-guided antibiotic therapy (selection of antibiotics guided by Gram staining of the endotracheal aspirate) N=103 guideline-based antibiotic therapy (combination of an anti-pseudomonal agent and anti- MRSA agent) Primary outcome Clinical response https://web.pathway.md/studies/recSj8dxIZWD0L9G8 1/2 6/28/23, 10:56 PM GRACE-VAP Pathway 76.7 % 76.7 71.8 57.5 % 38.4 % Difference not exceeding nonferiority margin 19.2 % 0.0 % Gram stain-guided antibiotic therapy Guideline-based antibiotic therapy Difference not exceeding nonferiority margin in clinical response (76.7% vs. 71.8%; AD 5%, 95% CI -7 to 17) Secondary outcomes No significant difference in death at day 28 (13.6% vs. 17.5%; HR 0.74, 95% CI 0.37 to 1.48) Significant decrease in the use of antipseudomonal agents (69.9% vs. 100%; ARD -30.1, 95% CI -21.5 to -39.9) Significant decrease in the use of anti-MRSA agents (61.2% vs. 100%; AD -38.8%, 95% CI -29.4 to -48.9) Safety outcomes No significant differences in adverse events, ICU-free days, ventilator-free days. Conclusion In patients with ventilator-associated pneumonia in the ICU, Gram stain-guided antibiotic therapy was noninferior to guideline-based antibiotic therapy with respect to clinical response. Reference Jumpei Yoshimura, Kazuma Yamakawa, Yoshinori Ohta et al. Effect of Gram Stain-Guided Initial Antibiotic Therapy on Clinical Response in Patients With Ventilator-Associated Pneumonia: The GRACE-VAP Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e226136. Open reference URL https://web.pathway.md/studies/recSj8dxIZWD0L9G8 2/2