UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053215 |
|---|---|
| Receipt number | R000060731 |
| Scientific Title | A study to evaluate the performance of the UF series bacterial count and Gram stainability information on clinical urine specimens used to test for bacterial infections. |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/25 13:59:04 |
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Basic information
Public title
A study to evaluate the performance of the UF series bacterial count and Gram stainability information on clinical urine specimens used to test for bacterial infections.
Acronym
Study on Performance Evaluation of UF Series for Urine Samples
Scientific Title
A study to evaluate the performance of the UF series bacterial count and Gram stainability information on clinical urine specimens used to test for bacterial infections.
Scientific Title:Acronym
Study on Performance Evaluation of UF Series for Urine Samples
Region
| Japan |
Condition
Condition
urinary tract infection
Classification by specialty
| Infectious disease | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bacterial counting performance in bacteria that are difficult to culture by urine culture method (difficult-to-culture bacteria) and evaluation of BACT-Info's discrimination performance against Gram-stained adventitious bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement rate, sensitivity and specificity of UF series results with results of urine culture tests and microscopic tests such as Gram stain
Key secondary outcomes
Evaluation of scattergrams of clinical urine specimens in comparison to ATCC strains or clinical isolates
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Cases in which UF-5000 assay, Gram stain, and urine culture were all ordered at the time of the usual examination.
Key exclusion criteria
Patients who have refused to participate in this study
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
yasuda7jpe@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
yasuda7jpe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
S1 W17, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.ac.jp
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
| 2023 | Year | 12 | Month | 25 | 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
| 2023 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The UF series will be evaluated in comparison with microbiological tests (urine culture test) and Gram stain as a control method to evaluate the performance of the UF series in measuring bacteria.
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060731
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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