UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040369 |
|---|---|
| Receipt number | 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 | 2021/05/12 17:21:37 |
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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
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
hidehashimoto-tky@umin.ac.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045999
| 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 |
