UMIN-CTR Clinical Trial

Basic information
Public title	Nationwide Surveillance Study on Urinary Antigen Test and Clinical Features in Diagnosis of Legionnaires' Disease -A Multicenter Prospective Observational Study
Acronym	Nationwide Surveillance Study on Urinary Antigen Test and Clinical Features in Diagnosis of Legionnaires' Disease
Scientific Title	Nationwide Surveillance Study on Urinary Antigen Test and Clinical Features in Diagnosis of Legionnaires' Disease -A Multicenter Prospective Observational Study
Scientific Title:Acronym	Nationwide Surveillance Study on Urinary Antigen Test and Clinical Features in Diagnosis of Legionnaires' Disease
Region	Japan

Condition
Condition	Legionnaires' disease
Classification by specialty	Medicine in general Pneumology Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The characteristics of various urinary antigen tests in confirmed cases of Legionnaires' disease will be reviewed.
Basic objectives2	Others
Basic objectives -Others	The clinical features of Legionnaires' disease caused by Legionella pneumophila Serogroup (SG) 1 and other SGs and other Legionella species will also be clarified.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Characteristics of various urinary antigen tests in confirmed cases of Legionnaires' disease
Key secondary outcomes	Comparison of clinical features of Legionnaires' disease caused by L. pneumophila SG1 and other SG and other Legionella spp.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Cases diagnosed as Legionnaires' disease by sputum culture, genetic test (LAMP method), or urine antigen test (2) Suspected cases who are suspected by the attending physician based on findings such as high fever, dry cough, hyponatremia, high LDH, high CRP, and thrombocytopenia, and who have been started on treatment for Legionnaires' disease after excluding pneumonia caused by other microorganisms.
Key exclusion criteria	Patients who did not give consent for the study
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Kazuyoshi Middle name Last name Kawakami
Organization	Tohoku University Graduate School
Division name	Department of Medical Microbiology, Mycology, and Immunology,
Zip code	980-8575
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL	022-717-7946
Email	kawakami@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ishii
Organization	Keio University School of Medicine
Division name	Division of Pulmonary Medicine, Department of Medicine
Zip code	160-8582
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	0333531211
Homepage URL
Email	ishii@keio.jp

Sponsor
Institute	Department of Medical Microbiology, Mycology, and Immunology, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	The Infectious Diseases Society of Japan, Eiken Chemical, Abbott Diagnostics Medical Co., Ltd. , Mizuhomedi, and Kyokuto Pharmaceutical Industries, Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee, Graduate School of Medicine, Tohoku University
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
Tel	022-728-4105
Email	med-kenkyo@grp.tohoku.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	2021 Year 10 Month 27 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	2021 Year 10 Month 19 Day
Date of IRB	2021 Year 10 Month 26 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2023 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a multicenter prospective observational study. Clinical Research Ethics Committee, Tohoku University Hospital

Management information
Registered date	2021 Year 10 Month 26 Day
Last modified on	2021 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052155