UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018119
Receipt number R000020831
Scientific Title 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
Date of disclosure of the study information 2015/06/30
Last modified on 2016/11/25 13:38:34

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Basic information

Public title

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

Acronym

Gram negative bacteremia (Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca or Proteus spp.)

Scientific Title

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiromichi Suzuki

Organization

Tsukuba Medical Center Hospital

Division name

Division of Infectious Diseases, Department of Medicine/Department of Clinical Laboratory Medicine

Zip code


Address

1-3-1 Amakubo, Tsukuba, Ibaraki

TEL

81-29-851-3511

Email

hsuzuki@tmch.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromichi Suzuki

Organization

Tsukuba Medical Center Hospital

Division name

Division of Infectious Diseases, Department of Medicine/Department of Clinical Laboratory Medicine

Zip code


Address

1-3-1 Amakubo, Tsukuba, Ibaraki

TEL

81-29-851-3511

Homepage URL


Email

hsuzuki@tmch.or.jp


Sponsor or person

Institute

Tsukuba Medical Center Hospital

Institute

Department

Personal name



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


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

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


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


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

2015 Year 05 Month 30 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020831


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name