UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039433 |
|---|---|
| Receipt number | 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 | 2021/02/08 07:46:24 |
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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
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
hidehashimoto-tky@umin.ac.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044955
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
