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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040369
Receipt No. R000045999
Scientific Title Evaluation of novel blood culture identification panel (FilmArray BCID2) for antibiotic therapy of blood stream infections
Date of disclosure of the study information 2020/05/11
Last modified on 2020/05/11

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Basic information
Public title Evaluation of novel blood culture identification panel for blood stream infections
Acronym Evaluation of novel blood culture identification panel for blood stream infections
Scientific Title Evaluation of novel blood culture identification panel (FilmArray BCID2) for antibiotic therapy of blood stream infections
Scientific Title:Acronym Evaluation of novel blood culture identification panel (FilmArray BCID2) for antibiotic therapy of blood stream infections
Region
Japan

Condition
Condition Gram-negative bacteremia
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate virtually the clinical significance of rapid identification of bacteria and resistance genes with novel panel of multiplex PCR system (FilmArray BCID2) for blood stream infection by comparing with conventional panel (FilmArray BCID1).
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 Days of therapy with broad-spectrum antibiotics

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1) Intervention (Virtual)
Antibiotic therapy based on the microorganism identification by conventional method and Filmarray system (BCID2 panel)
*Hypothetical intervention using residual positive blood culture samples
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 1) Patients with gram negative bacteremia detected by the BacT/ALERT 3D system and identified by FilmArray system (BCID1 panel).
Key exclusion criteria 1)If patients have already been referred or transferred to other hospitals.
2)If patients are not hospitalized in Hitachi General Hospital.
3)If palliative care is performed without treatment for infections.
4)If patients have already died at the time of reporting the results of Gram staining.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Hashimoto
Organization Hitachi General Hospital
Division name Division of Emergency and Critical Care Medicine, Division of Infectious Diseases
Zip code 3170077
Address 2-1-1, Jonancho, Hitachi, Ibaraki, Japan
TEL 0294-23-1111
Email hidehashimoto-tky@umin.ac.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 Critical Care Medicine, Division of Infectious Diseases
Zip code 3170077
Address 2-1-1, Jonancho, Hitachi, Ibaraki, Japan
TEL 0294-23-1111
Homepage URL
Email hidehashimoto-tky@umin.ac.jp

Sponsor
Institute Hitachi General Hospital
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hitachi General Hospital
Address 2-1-1, Jonancho, Hitachi, Ibaraki, Japan
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 日立総合病院(茨城県)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 11 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 04 Month 21 Day
Date of IRB
2020 Year 04 Month 27 Day
Anticipated trial start date
2020 Year 05 Month 11 Day
Last follow-up date
2020 Year 09 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
2020 Year 05 Month 11 Day
Last modified on
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045999

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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