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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041080
Receipt No. 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 2020/07/12

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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 PCR" 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
Email 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
Email kawatake@chiba-u.jp

Sponsor
Institute Department of Respirology, Graduate School of Medicine, Chiba University
Institute
Department

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
Email 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
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 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
2020 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046912

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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