UMIN-CTR Clinical Trial

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	150
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 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	2021 Year 02 Month 08 Day

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