UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045880 |
|---|---|
| Receipt number | R000052155 |
| Scientific Title | Nationwide Surveillance Study on Urinary Antigen Test and Clinical Features in Diagnosis of Legionnaires' Disease -A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2021/10/27 |
| Last modified on | 2021/11/01 13:05:54 |
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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
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
ishii@keio.jp
Sponsor or person
Institute
Department of Medical Microbiology, Mycology, and Immunology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052155
