UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of Gram stain results on initial treatment selection in patients with ventilator-associated pneumonia: a retrospective analysis of two treatment algorithms
Title of the study (Brief title)	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	Satoshi Fujimi
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	fujimis@opho.jp

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	2017 Year 03 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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)).
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