GRam Stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) Trial
Status:
Active, not recruiting
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
Summary
Background: Optimising the use of antibiotic agents is a pressing challenge to overcoming the
rapid emergence and spread of multidrug-resistant pathogens in intensive care units (ICUs).
Although Gram staining may possibly provide immediate information for predicting pathogenic
bacteria, Gram stain-guided initial antibiotic treatment is not well established in the ICU
setting. The investigators planned the GRam stain-guided Antibiotics ChoicE for
Ventilator-Associated Pneumonia (GRACE-VAP) trial to investigate whether Gram staining can
safely restrict the use of broad-spectrum antibiotics in patients with ventilator-associated
pneumonia (VAP), which is one of the most common hospital-acquired infections in ICUs.
Methods/Design: The GRACE-VAP trial is a multicenter, randomised, open-label parallel-group
trial to assess the non-inferiority of Gram stain-guided initial antibiotic treatment to
guidelines-based initial antibiotic treatment for the primary endpoint of clinical cure rate
in patients with VAP. Secondary endpoints include the coverage rates of initial antibiotic
therapies, the selected rates of anti-pseudomonal agents and anti-methicillin-resistant
Staphylococcus aureus (MRSA) agents as initial antibiotic therapies, 28-day all-cause
mortality, ICU-free days, ventilator-free days, and adverse events. Participants are randomly
assigned to receive Gram stain-guided treatment or guidelines-based treatment at a ratio of
1:1. In the Gram stain group, results of Gram staining of endotracheal aspirate are used to
guide the selection of antibiotics. In the guidelines group, the combination of an
anti-pseudomonal agent and anti-MRSA agent are administered. A total sample size of 200 was
estimated to provide a power of 80% with a 1-sided alpha level of 2.5% and a non-inferiority
margin of 20%, considering 10% non-evaluable participants.
Discussion: The GRACE-VAP trial is expected reveal whether Gram staining can reduce the use
of broad-spectrum antibiotics without impairing patient outcomes and thereby provide evidence
for an antibiotics selection strategy in patients with VAP.
Phase:
Phase 4
Details
Lead Sponsor:
Osaka General Medical Center
Collaborators:
Chukyo Hospital Ebina General Hospital Hitachi General Hospital Kansai Medical University Kansai Medical University Medical Center Nagasaki University Saga University Sapporo City General Hospital Tajima Emergency and Critical Care Medical Center University of the Ryukyus Wakayama Medical University