UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014399
Receipt number R000016547
Scientific Title Evaluation of infectious disease consultations with a rapid microbiological identification system (Verigene system) for Gram-positive and Gram-negative bacteremia
Date of disclosure of the study information 2014/06/29
Last modified on 2016/06/27 09:49:57

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Basic information

Public title

Evaluation of infectious disease consultations with a rapid microbiological identification system (Verigene system) for Gram-positive and Gram-negative bacteremia

Acronym

Evaluation of infectious disease consultations with a rapid microbiological identification system (Verigene system) for Gram-positive and Gram-negative bacteremia

Scientific Title

Evaluation of infectious disease consultations with a rapid microbiological identification system (Verigene system) for Gram-positive and Gram-negative bacteremia

Scientific Title:Acronym

Evaluation of infectious disease consultations with a rapid microbiological identification system (Verigene system) for Gram-positive and Gram-negative bacteremia

Region

Japan


Condition

Condition

Gram-positive 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 rapid identification with the Verigene system for Gram-positive and Gram-negative bacteremia by comparing it with conventional microbiological identification methods.

Basic objectives2

Others

Basic objectives -Others

Efficacy

Trial characteristics_1

Confirmatory

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 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

80


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

029-851-3511

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

029-851-3511

Homepage URL

http://www.tmch.or.jp/hosp/

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

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)、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 06 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


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

2014 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2015 Year 01 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 06 Month 27 Day

Last modified on

2016 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016547


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name