UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of infectious disease consultations with a rapid microbiology identification system (Verigene system) for Gram-positive bacteremia and Gram-negative bacteremia (additional research)
Title of the study (Brief title)	Evaluation of infectious disease consultations with a rapid microbiology identification system (Verigene system) for Gram-positive bacteremia and Gram-negative bacteremia (additional research)
Region	Japan

Condition
Condition	Gram-positive bacteremia and Gram-negative bacteremia
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the clinical significance of a rapid identification with Verigene system for Gram-positive bacteremia and Gram-negative bacteremia by comparing it with conventional microbiological identification methods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Duration before the initiation of appropriate antimicrobial therapy after obtaining blood cultures.
Key secondary outcomes	1)Additional cost requirement of antimicrobial agents compared with appropriate antimicrobial therapy 2)14 days mortality 3)30 days mortality

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1) Control Clinical management with conventional microbiological identification methods
Interventions/Control_2	2) Intervention Clinical management with conventional microbiological identification methods and Verigene system.
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	Gram positive bacteremia or Gram negative bacteremia detected by BacT/Alert 3D system (Sysmex bioMerieux Co., Ltd, Tokyo, Japan)
Key exclusion criteria	1)If only one set of blood cultures is positive among two sets of blood cultures incubated, and Staphylococcus spp. or Gram-positive rods are suspected by Gram stain examination. 2)If one set of blood culture is positive with Staphylococcus spp. suspected by Gram stain examination and contamination is clinically considered. 3)If blood cultures are positive and Gram-positive rods are suspected in nosocomial bacteremia patients. 4)If differentiation between Gram-positive and Gram-negative bacteria is difficult by Gram stain examination. 5)If more than two species of bacteria are suspected by Gram stain examination. 6)If more than 24 hours have passed after positive blood culture alarm by BacT/Alert 3D system. 7)If Gram stain examination of positive blood culture indicates the same bacteria as previous positive blood culture obtained within the past week. 8)If patients have already been referred or transferred to other hospitals. 9)If patients are not hospitalized in Tsukuba Medical Center Hospital. 10)If palliative care is performed without treatment for infections. 11)If patients have already died at the time of reporting the results of Gram staining.
Target sample size	40

Research contact person
Name of lead principal investigator	Hiromichi Suzuki
Organization	Tsukuba Medical Center Hospital
Division name	Division of Infectious Diseases, Department of Medicine/Department of Clinical Laboratory Medicine
Address	1-3-1 amakubo, Tsukuba, Ibaraki
TEL	81-29-851-3511
Email	hsuzuki@tmch.or.jp

Public contact
Name of contact person	Hiromichi Suzuki
Organization	Tsukuba Medical Center Hospital
Division name	Division of Infectious Diseases, Department of Medicine/Department of Clinical Laboratory Medicine
Address	1-3-1 amakubo, Tsukuba, Ibaraki
TEL	81-29-851-3511
Homepage URL
Email	hsuzuki@tmch.or.jp

Sponsor
Institute	Tsukuba Medical Center Hospital
Institute
Department

Funding Source
Organization	Hitachi High-Technologies Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Miroku Medical Laboratory Inc.
Name of secondary funｄer(s)	Tsukuba Medical Center Hospital

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	筑波メディカルセンター病院（茨城県）、ミロクメディカルラボラトリー（長野県）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 24 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 30 Day
Last modified on	2016 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018687