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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026457
Receipt No. R000030392
Scientific Title Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Date of disclosure of the study information 2017/03/08
Last modified on 2017/03/08

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Basic information
Public title Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Acronym Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Scientific Title Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Scientific Title:Acronym Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Region
Japan

Condition
Condition ventilator-associated penumonia
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate whether a Gram stain of endotracheal aspirates could be used to determine appropriate initial antimicrobial therapy for VAP.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The coverage rates of initial antimicrobial therapies.
Key secondary outcomes The selected rates of anti-pseudomonal agents and anti-MRSA agents

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were treated for ventilator-associated pneumonia were eligible for this study.
Key exclusion criteria modified clinical pulmonary infection score (CPIS) less than 5.
semi-quantitative growth of a respiratory pathogen using a respiratory sample was estimated to be less than 1+.
Target sample size 219

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Fujimi
Organization Osaka General Medical Centre
Division name Division of Trauma and Surgical Critical Care
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
TEL 06-6692-1201
Email fujimis@opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kinoshita
Organization Osaka General Medical Centre
Division name Division of Trauma and Surgical Critical Care
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
TEL 06-6692-1201
Homepage URL
Email ogmc.dmat.t.kinoshita@gmail.com

Sponsor
Institute Osaka General Medical Centre
Institute
Department

Funding Source
Organization Osaka General Medical Centre
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 08 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
Antimicrobial choices proposed by the Guideline based algorithm and the Gram stain based algorithm were appropriate in 94.7% and 92.4% of cases, respectively. McNemar's test showed no significant difference in adequacy for the different strategies (p = 0.221). The Gram stain based algorithm proposed anti-methicillin-resistant Staphylococcus aureus agents in significantly fewer episodes than the Guideline based algorithm (41 (31.3%) versus 92 (70.2%), respectively (p < 0.001)). The Gram stain based algorithm also recommended antipseudomonal agents in significantly fewer episodes than the Guideline based algorithm (68 (51.9%) versus 92 (70.2%), respectively (p < 0.001)).
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 Completed
Date of protocol fixation
2016 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 22 Day
Last follow-up date
2016 Year 06 Month 22 Day
Date of closure to data entry
2016 Year 06 Month 22 Day
Date trial data considered complete
2016 Year 06 Month 22 Day
Date analysis concluded
2017 Year 02 Month 01 Day

Other
Other related information To evaluate whether Gram stain of endotracheal aspirate was a reliable guide for the selection of antimicrobial therapy for VAP, we constructed 2 hypothetical empirical antimicrobial treatment algorithms: a guidelines-based algorithm (GLBA) and a Gram stain-based algorithm (GSBA). Both the GLBA and the GSBA were hypothetically applied to the same VAP episodes and the antimicrobial agents proposed by each algorithm were compared retrospectively. Therapy was considered appropriate when all pathogens involved in the VAP episode were covered by antimicrobial agents.

Management information
Registered date
2017 Year 03 Month 08 Day
Last modified on
2017 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030392

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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