UMIN-CTR Clinical Trial

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	50
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	No longer recruiting
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	2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 05 Month 11 Day
Last modified on	2021 Year 05 Month 12 Day

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