UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041080 |
|---|---|
| Receipt number | R000046912 |
| Scientific Title | The utility of urinary antigen detection for diagnosis of legionellosis: systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/07/12 |
| Last modified on | 2024/07/15 10:24:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The utility of urinary antigen detection for diagnosis of legionellosis: systematic review and meta-analysis
Acronym
The utility of urinary antigen detection for diagnosis of legionellosis: systematic review and meta-analysis
Scientific Title
The utility of urinary antigen detection for diagnosis of legionellosis: systematic review and meta-analysis
Scientific Title:Acronym
The utility of urinary antigen detection for diagnosis of legionellosis: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Legionellosis
Classification by specialty
| Pneumology | Infectious disease | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of urinary antigen detection for legionellosis
Basic objectives2
Others
Basic objectives -Others
Accuracy of a test
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of urinary antigen detection for legionellosis
Key secondary outcomes
Complications
Costs
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with legionellosis and people without legionellosis
2. People who received tests of "urinary antigen detection" and "sputum culture or sputum PCR or serum antibody" for legionellosis
Key exclusion criteria
Nothing special
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1, Inohana, Chuoku, Chiba-city, Chiba-prefecture,
TEL
043-222-7171
kawatake@chiba-u.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1, Inohana, Chuoku, Chiba-city, Chiba-prefecture
TEL
043-222-7171
Homepage URL
kawatake@chiba-u.jp
Sponsor or person
Institute
Department of Respirology, Graduate School of Medicine, Chiba University
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
Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuoku, Chiba-city, Chiba-prefecture
Tel
043-222-7171
kawatake@chiba-u.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
| 2020 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S2212534521002124?via%3Dihub
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S2212534521002124?via%3Dihub
Number of participants that the trial has enrolled
5772
Results
The calculated pooled sensitivity and specificity were 0.79 and 1.00, respectively. Subpopulation analysis revealed that the accuracy of UATs for sensitivity and specificity for Legionella pneumophilia serogroup 1 was 0.86 and 1.00, respectively.
Results date posted
| 2024 | Year | 07 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Overall, 1326 studies were screened, 21 of which fulfilled the eligibility criteria for quality assessment and meta-analysis.
Participant flow
Data from 5772 patients, including 1368 (23.7%) with the target condition (i.e., suspected legionellosis), were included in the analysis. The overall quality of the included studies, which was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, was unclear.
Adverse events
None
Outcome measures
The calculated pooled sensitivity and specificity were 0.79 and 1.00, respectively. Subpopulation analysis revealed that the accuracy of UATs for sensitivity and specificity for Legionella pneumophilia serogroup 1 was 0.86 and 1.00, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 12 | Day |
Date of IRB
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]
Observational studies written in English in MEDLINE or CENTRAL database will be evaluated.
[Data extraction and management/Assessment of risk of bias]
Two reviewers 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 using the random-effects model if studies are not heterogeneous.
[Subgroup analysis]
We will perform the subgroup analyses if available to evaluate the following items: the differences in accuracy of the test among kits, between analysis periods, or by ages, and the accuracy in pneumonia cases.
[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 | 12 | Day |
Last modified on
| 2024 | 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=R000046912
