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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014399
Receipt No. 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

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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
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

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
URL(English) https://upload.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


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