UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter evaluation of the Verigene Gram-Negative Blood Culture Nucleic Acid Test on the impact of resistance gene determinant for the prediction of susceptibility of Enterobacteriaceae to third-generation cephalosporin in Japan
Title of the study (Brief title)	Gram negative bacteremia (Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca or Proteus spp.)
Region	Japan

Condition
Condition	Gram negative bacteremia (Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca or Proteus spp.)
Classification by specialty	Infectious disease Laboratory medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the Verigene Gram-Negative Blood Culture Nucleic Acid Test on the impact of resistance gene determinant for the prediction of susceptibility of Enterobacteriaceae to third-generation cephalosporin
Basic objectives2	Others
Basic objectives -Others	Clinical evaluation
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Cefotaxime susceptibility of Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus spp. when resistance genes are not detected by Verigene system with BC-GN panel
Key secondary outcomes	(i)Susceptibility of each Enterobacteriaceae to cefotaxime when resistance genes are not detected by Verigene system with BC-GN panel (ii)Detection rate of resistance genes by Verigene BC-GN panel among each Enterobacteriaceae with non-susceptible to cefotaxime (iii)Antimicrobial susceptibilities of each Enterobacteriaceae when blaCTX-M is detected by Verigene system with BC-GN panel

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	(i)Tsukuba Medical Center Hospital The blood of Gram negative bacteremia detected by the BacT/ALERT 3D system (ii)Other hospitals or the Miroku Medical Laboratory Strains of Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca or Proteus spp. without in vitro susceptibility to third-generation cephalosporin (cefotaxime MIC = 2ug/mL or more) isolated from the blood of positive blood culture bottles incubated by automated blood culture systems.
Key exclusion criteria	(i) If strains and patient information are not available for clinical research purpose (ii) If evaluation with Verigene system is not able to be performed
Target sample size	100

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	Tsukuba Medical Center Hospital Seirei Hamamatsu General Hospital Seirei Mikatahara General Hospital Hitachi General Hospital Chutoen General Medical Center Akashi Medical Center 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）、聖隷浜松病院（静岡県）、聖隷三方原病院（静岡県）、日立総合病院（茨城県）、中東遠総合医療センター（静岡県）、明石医療センター（兵庫県）、株式会社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	2015 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 30 Day
Anticipated trial start date	2015 Year 07 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	Unpublished
URL releasing results
Results
Other related information	Prospective observational study

Management information
Registered date	2015 Year 06 Month 29 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=R000020831