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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031933
Receipt No. R000036420
Scientific Title GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial
Date of disclosure of the study information 2018/03/28
Last modified on 2020/05/31

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Basic information
Public title GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial
Acronym GRACE-VAP trial
Scientific Title GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial
Scientific Title:Acronym GRACE-VAP trial
Region
Japan

Condition
Condition Ventilator-Associated Pneumonia (VAP)
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether Gram stain-guided antibiotic treatment is non-inferior to guidelines-based treatment on the basis of the clinical cure in patients with VAP.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Clinical cure of VAP
Cure is defined as completion of antibiotic therapy within 14 days, improvement or lack of progression of baseline radiographic findings at the end of therapy (EOT), and resolution of signs and symptoms of pneumonia at the follow-up/test of cure visit (FU/TOC). Failure is defined as administration of study medication for 15 days or more, progression of radiological signs of pneumonia at EOT, or relapsed pneumonia at FU/TOC.
Key secondary outcomes Select of anti-pseudomonal agents as initial antibiotic therapies
Select of anti-MRSA agents as initial antibiotic therapies
Coverage of initial antibiotic therapies
28-day mortality
28-day ICU-free days
28-day ventilator-free days
Need of continuous renal replacement therapy
Duration of antibiotic therapy
De-escalation or escalation
Renal impairment
Thrombocytopenia
Clostridium difficile infection
The other adverse events related to antibiotics
Inflammation marker (CRP, PCT)
Organ failure control (SOFA)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 In the Gram stain 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. Specific antibiotic agents are selected according to previously recorded antimicrobial resistance patterns in each ICU. The study medication can be de-escalated or escalated to a definitive treatment level according to the results of the pathogens isolated from respiratory samples. Dose adjustments in the individual patients are performed as judged appropriate by the site investigator. Study medications are continued for at least 7 days and discontinued on the basis of the site investigator's judgement.
Interventions/Control_2 In the standard group, patients are administered the combination of an anti-pseudomonal agent and anti-MRSA agent according to IDSA/ATS guidelines. Specific antibiotic agents are selected according to previously recorded antimicrobial resistance patterns in each ICU. The study medication can be de-escalated or escalated to a definitive treatment level according to the results of the pathogens isolated from respiratory samples. Dose adjustments in the individual patients are performed as judged appropriate by the site investigator. Study medications are continued for at least 7 days and discontinued on the basis of the site investigator's judgement.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients undergoing mechanical ventilation in the ICU will be enroled in this study if they meet all the inclusion and none of the exclusion criteria. Patients will be included if they (1) are aged equal or more than 15 years; (2) have undergone mechanical ventilation for at least 48 hours; (3) are diagnosed as having VAP, which is defined by a modified clinical pulmonary infection score of 5 or more; and (4) or their representatives provide written, informed consent
Key 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.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Jumpei
Middle name
Last name Yoshimura
Organization Osaka General Medical Center
Division name Division of Trauma and Surgical Critical Care
Zip code 558-8558
Address 3-1-56 Bandai-Higashi, Sumiyoshi, Osaka 558-8558, Japan
TEL +81-6-6692-1201
Email jumpei.y0210@gmail.com

Public contact
Name of contact person
1st name Jumpei
Middle name
Last name Yoshimura
Organization Osaka General Medical Center
Division name Division of Trauma and Surgical Critical Care
Zip code 558-8558
Address 3-1-56 Bandai-Higashi, Sumiyoshi, Osaka 558-8558, Japan
TEL +81-6-6692-1201
Homepage URL
Email jumpei.y0210@gmail.com

Sponsor
Institute Division of Trauma and Surgical Critical Care, Osaka General Medical Center
Institute
Department

Funding Source
Organization Division of Trauma and Surgical Critical Care, Osaka General Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee, Osaka General Medical Center
Address 3-1-56 Bandai-Higashi, Sumiyoshi, Osaka 558-8558, Japan
Tel +81-6-6692-1201
Email kenkyusien@gh.opho.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長崎大学病院(長崎県)
関西医科大学附属枚方病院(大阪府)
関西医科大学総合医療センター(大阪府)
佐賀大学医学部附属病院(佐賀県)
日立総合病院(茨城県)
中京病院(愛知県)
海老名総合病院(神奈川県)
和歌山県立医科大学附属病院(和歌山県)
琉球大学医学部附属病院(沖縄県)
公立豊岡病院 但馬救命救急センター(兵庫県)
市立札幌病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 03 Month 19 Day
Date of IRB
2017 Year 12 Month 06 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2020 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036420

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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