UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043912 |
|---|---|
| Receipt number | R000050107 |
| Scientific Title | Clinical evaluation of detecting urine ribosomal protein L7/L12 for S.aureus and P.aeruginosa in patients with bacterial pneumonia |
| Date of disclosure of the study information | 2021/04/13 |
| Last modified on | 2021/08/18 19:32:03 |
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Basic information
Public title
Clinical evaluation of detecting urine ribosomal protein L7/L12 for S.aureus and P.aeruginosa in patients with bacterial pneumonia
Acronym
Clinical evaluation of detecting urine ribosomal protein L7/L12 for S.aureus and P.aeruginosa in patients with bacterial pneumonia
Scientific Title
Clinical evaluation of detecting urine ribosomal protein L7/L12 for S.aureus and P.aeruginosa in patients with bacterial pneumonia
Scientific Title:Acronym
Clinical evaluation of detecting urine ribosomal protein L7/L12 for S.aureus and P.aeruginosa in patients with bacterial pneumonia
Region
| Japan |
Condition
Condition
pneumonia, bacteremia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if ribosomal protein L7/L12 for S.aureus and P.aeruginosa can be detected in urine from patients with pneumonia and/or bacteremia by using
Basic objectives2
Others
Basic objectives -Others
diagnostic utility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance between positive sputum or blood culture for S.aureus or P.aeruginosa and detection of its ribosomal protein L7/L12 in urine
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- positive sputum and/or blood culture for S.aureus and/or P.aeruginosa with residual urine sample
Key exclusion criteria
- positive sputum and/or blood culture for targeted bacteria as well as bacteria with possible cross-reaction
- positive urine culture for targeted bacteria and/or bacteria with possible cross-reaction
- simultaneous infection focus other than lung due to targeted bacteria and/or bacteria with cross-reaction in patient with pneumonia
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Iwata |
Organization
National Cancer Center Hospital
Division name
Department of Infectious Diseases
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
siwata@ncc.go.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Shiotsuka |
Organization
National Cancer Center Hospital
Division name
Department of Infectious Diseases
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
mshiotsu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei 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
National Cancer Center IRB
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
NCC_IRBoffice@ml.res.ncc.go.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
| 2021 | Year | 04 | Month | 13 | 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
28
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluating concordance between bacteria cultured from blood or sputum and those of which ribosomal protein L7/L12 detected from urine
Management information
Registered date
| 2021 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050107
