UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041081 |
|---|---|
| Receipt number | R000046915 |
| Scientific Title | Diagnostic accuracy of Urinary Antigen Test for Pneumococcal pneumonia in adults: Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2020/07/13 |
| Last modified on | 2022/07/15 13:21:23 |
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Basic information
Public title
Diagnostic accuracy of Urinary Antigen Test for Pneumococcal pneumonia in adults: Systematic Review and Meta-Analysis
Acronym
Diagnostic accuracy of Urinary Antigen Test for Pneumococcal pneumonia in adults: Systematic Review and Meta-Analysis
Scientific Title
Diagnostic accuracy of Urinary Antigen Test for Pneumococcal pneumonia in adults: Systematic Review and Meta-Analysis
Scientific Title:Acronym
Diagnostic accuracy of Urinary Antigen Test for Pneumococcal pneumonia in adults: Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
pneumococcal pneumonia
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the diagnostic accuracy of urinary pneumococcal antigen testing for patients with suspected acute respiratory failure or pneumonia.
Basic objectives2
Others
Basic objectives -Others
diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic accuracy of urinary antigen test for pneumococcal pneumonia
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1)Patients with acute respiratory insufficiency
2)Patients with suspected pneumonia
Key exclusion criteria
Nothing special
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yasuo |
Organization
Kyoto Katsura Hospital
Division name
Department of Emergency Medicine
Zip code
6158256
Address
17, Yamada Hirao-cho, Nishikyo-ku, Kyoto city, Kyoto prefecture, Japan
TEL
075-391-5811
yasuoshun@gmail.com
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yasuo |
Organization
Kyoto Katsura Hospital
Division name
Department of Emergency Medicine
Zip code
6158256
Address
17, Yamada Hirao-cho, Nishikyo-ku, Kyoto city, Kyoto prefecture, Japan
TEL
075-391-5811
Homepage URL
yasuoshun@gmail.com
Sponsor or person
Institute
Kyoto Katsura Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Katsura Hospital
Address
17, Yamada Hirao-cho, Nishikyo-ku, Kyoto city, Kyoto prefecture, Japan
Tel
075-391-5811
yasuoshun@gmail.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 | 07 | 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
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 | 07 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Database]
MEDLINE, CENTRAL, etc
Observational studies written in English are included.
[Data extraction and management/Assessment of risk of bias]
Two review authors will independently extract data from included articles, and assess the risk of bias of them. We will resolve any disagreement through discussion. We will consult a third review author if we disagree with each other.
[Meta-analysis]
We will perform a quantitative analysis when studies are not heterogeneous. Random effects models will be used.
[Subgroup analysis]
We will perform the subgroup analyses if available to evaluate the following items: Accuracy by test kits / Accuracy by Period of Coverage / Accuracy by Age of Coverage / Accuracy in Acute Respiratory Failure / Accuracy in Suspected Pneumonia
[Sensitivity analysis]
We will assess the robustness by excluding the studies with a high risk of bias.
Management information
Registered date
| 2020 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046915
