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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039433
Receipt No. R000044955
Scientific Title Randomized Trial of Multiplex real-time PCR-based antibiotic therapy for severe bloodstream infections
Date of disclosure of the study information 2020/02/08
Last modified on 2020/02/08

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Basic information
Public title Randomized Trial of Multiplex real-time PCR-based antibiotic therapy for severe bloodstream infections
Acronym Randomized Trial of Multiplex real-time PCR-based antibiotic therapy for severe bloodstream infections
Scientific Title Randomized Trial of Multiplex real-time PCR-based antibiotic therapy for severe bloodstream infections
Scientific Title:Acronym Randomized Trial of Multiplex real-time PCR-based antibiotic therapy for severe bloodstream infections
Region
Japan

Condition
Condition bacteremia
Classification by specialty
Infectious disease Intensive care medicine Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical significance of rapid identification of bacteria and resistance genes with multiplex PCR system (Filmarray and Verigene system) for severe blood stream infection by comparing with conventional microbiological identification methods.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration between the identification of positive blood cultures and the initiation of appropriate antibiotic therapy.
Key secondary outcomes 1) 28 day-mortality
2) Duration of ICU stay
3) Duration of hospital stay
4) Total cost of antimicrobial agents

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1) Intervention 1
Antibiotic therapy based on the microorganism identification by conventional method and Filmarray system
Interventions/Control_2 2) Intervention 2
Antibiotic therapy based on the microorganism identification by conventional method and Verigene system
Interventions/Control_3 3) Control
Antibiotic therapy based on the microorganism identification by conventional method
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 1) Patients with positive blood cultures who are hospitalized in the incentive care unit or high care unit in the Hitachi General Hospital.
2) Patients whose antibiotic treatment intensivists and antibiotic stewardship team choose.
Key exclusion criteria 1) Suspected persistent bacteremia (positive blood cultures of the same bacteria based on gram stain examination) within the past week.
2) If no bacteria is shown on gram stain examination despite positive blood cultures.
3) If more than 48 hours have passed after positive blood cultures.
4) Receiving palliative care without antibiotic therapy.
5) If patients are not hospitalized in the ICU/HCU (due to death or transfer to another hospital/department).
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kensuke
Middle name
Last name Nakamura
Organization Hitachi General Hospital
Division name Division of Emergency and Intensive Care Medicine
Zip code 3170077
Address 2-1-1, Jonan-cho, Hitachi, Ibaraki
TEL 81-0294-23-1111
Email mamashockpapashock@yahoo.co.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Hashimoto
Organization Hitachi General Hospital
Division name Division of Emergency and Intensive Care Medicine/Department of Infectious Diseases
Zip code 3170077
Address 2-1-1, Jonan-cho, Hitachi, Ibaraki
TEL 81-0294-23-1111
Homepage URL
Email hidehashimoto-tky@umin.ac.jp

Sponsor
Institute Hitachi General Hospital
Institute
Department

Funding Source
Organization None.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hitachi General Hospital Ethics Comittee
Address 2-1-1, Jonan-cho, Hitachi, Ibaraki
Tel 0294-23-1111
Email masahiro.miura.cz@hitachi.com

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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 08 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 Enrolling by invitation
Date of protocol fixation
2020 Year 01 Month 28 Day
Date of IRB
2020 Year 02 Month 06 Day
Anticipated trial start date
2020 Year 02 Month 08 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 08 Day
Last modified on
2020 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044955

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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