GRam Stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) Trial
NCT ID: NCT03506113
Last Updated: 2022-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
206 participants
INTERVENTIONAL
2018-04-01
2020-06-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Gram stain-guided therapy group
The results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics. The results of the Gram stains are categorised as Gram-positive cocci (GPC) chains, GPC clusters, Gram-positive bacilli (GPB), Gram-negative rods (GNR), or a combination of these. A non-pseudomonal beta-lactam antibiotic is selected when the Gram stain of the endotracheal aspirate shows only GPC chains and/or GPB. An anti-MRSA agent is selected when the Gram stain results show GPC clusters without GNR. An anti-pseudomonal agent is selected when the Gram stain results show GNR without GPC clusters. The combination of an anti-pseudomonal agent and an anti-MRSA agent is selected when the Gram stain results show both GPC clusters and GNR.
Gram stain-guided antibiotic choice
The results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics.
Guidelines-based therapy group
Patients are administered the combination of an anti-pseudomonal agent and anti-MRSA agent according to the Infectious Disease Society of America and the American Thoracic Society (IDSA/ATS) guidelines because 47.7% of S. aureus isolates are MRSA in Japanese ICUs
Guidelines-based antibiotics choice
Patients are administered the combination of an anti-pseudomonal agent and anti-MRSA agent according to IDSA/ATS guidelines
Interventions
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Gram stain-guided antibiotic choice
The results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics.
Guidelines-based antibiotics choice
Patients are administered the combination of an anti-pseudomonal agent and anti-MRSA agent according to IDSA/ATS guidelines
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing mechanical ventilation for at least 48 hours
* Patients diagnosed as having VAP, which is defined by a modified clinical pulmonary infection score of 5 or more
* Patients declined to provide full life support
* Patients judged as inappropriate at the discretion of the study physician.
Exclusion Criteria
* Pregnant patients
* Patients discharged from ICU
* Patients diagnosed as having heart failure or atelectasis
15 Years
ALL
No
Sponsors
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Chukyo Hospital
UNKNOWN
Ebina General Hospital
UNKNOWN
Hitachi General Hospital
UNKNOWN
Kansai Medical University
OTHER
Kansai Medical University Medical Center
UNKNOWN
Nagasaki University
OTHER
Saga University
OTHER
University of the Ryukyus
OTHER
Wakayama Medical University
OTHER
Tajima Emergency and Critical Care Medical Center
UNKNOWN
Sapporo City General Hospital
UNKNOWN
Osaka General Medical Center
OTHER
Responsible Party
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Jumpei Yoshimura, MD
Dr.
Principal Investigators
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Jumpei Yoshimura, MD
Role: PRINCIPAL_INVESTIGATOR
Osaka General Medical Center
Kazuma Yamakawa, MD, PhD
Role: STUDY_DIRECTOR
Osaka General Medical Center
Takeshi Morimoto, MD, PhD, MPH
Role: STUDY_DIRECTOR
Hyogo Medical University
Locations
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Chukyo Hospital
Nagoya, Aichi-ken, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Tajima Emergency and Critical Care Medical Center
Toyooka, Hyōgo, Japan
Hitachi General Hospital
Hitachi, Ibaraki, Japan
Ebina General Hospital
Ebina, Kanagawa, Japan
University of the Ryukyus Hospital
Nishihara, Okinawa, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kansai Medical University Medical Center
Moriguchi, Osaka, Japan
Nagasaki University Hospital
Nagasaki, , Japan
Osaka General Medical Center
Osaka, , Japan
Saga University Hospital
Saga, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Countries
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References
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Yoshimura J, Yamakawa K, Ohta Y, Nakamura K, Hashimoto H, Kawada M, Takahashi H, Yamagiwa T, Kodate A, Miyamoto K, Fujimi S, Morimoto T. 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. doi: 10.1001/jamanetworkopen.2022.6136.
Yoshimura J, Yamakawa K, Kinoshita T, Ohta Y, Morimoto T. GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial: rationale and study protocol for a randomised controlled trial. Trials. 2018 Nov 8;19(1):614. doi: 10.1186/s13063-018-2971-2.
Other Identifiers
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UMIN000031933
Identifier Type: REGISTRY
Identifier Source: secondary_id
29-C0707
Identifier Type: -
Identifier Source: org_study_id
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