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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034845
Receipt No. R000031136
Official scientific title of the study Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a prospective observation study
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/10

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Basic information
Official scientific title of the study Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a prospective observation study
Title of the study (Brief title) Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a prospective observation study
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to validate the clinical response of Gram stain-guided antibiotic therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The clinical response rates
Key secondary outcomes 1, The selected rates of anti-pseudomonal agents and anti-MRSA agents
2, The coverage rates of initial antibiotic therapies.

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who had a modified clinical pulmonary infection score of 5 or more and were diagnosed ventilator-associated pneumonia
Key exclusion criteria Patients who do not want aggressive treatment
Pregnant women
Patients leaving ICU
Target sample size 20

Research contact person
Name of lead principal investigator Takahiro Kinoshita
Organization Osaka General Medical Centre
Division name Division of Trauma and Surgical Critical Care
Address 3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
TEL 06-6692-1201
Email ogmc.dmat.t.kinoshita@gmail.com

Public contact
Name of contact person Takahiro Kinoshita
Organization Osaka General Medical Centre
Division name Division of Trauma and Surgical Critical Care
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)

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
2018 Year 11 Month 10 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 22 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia

Management information
Registered date
2018 Year 11 Month 10 Day
Last modified on
2018 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031136

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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