UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043261 |
|---|---|
| Receipt number | R000049376 |
| Scientific Title | Comparison of Ribotest Legionella and Immunocatch Legionella for diagnosing Legionella pneumonia: A multicenter, prospective, observational study |
| Date of disclosure of the study information | 2021/02/08 |
| Last modified on | 2024/03/27 19:41:22 |
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Basic information
Public title
Comparison of Ribotest Legionella and Immunocatch Legionella for diagnosing Legionella pneumonia: A multicenter, prospective, observational study
Acronym
Comparison of Ribotest and Immunocatch for diagnosing Legionella pneumonia
Scientific Title
Comparison of Ribotest Legionella and Immunocatch Legionella for diagnosing Legionella pneumonia: A multicenter, prospective, observational study
Scientific Title:Acronym
Comparison of Ribotest and Immunocatch for diagnosing Legionella pneumonia
Region
| Japan |
Condition
Condition
Legionella pneumonia
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic accuracies of Ribotest Legionella and Immunocatch Legionella for Legionella pneumonia.
Basic objectives2
Others
Basic objectives -Others
To clarify the clinical characteristics of Legionella pneumonia due to non-Legionella pneumophila serogroup 1.
To validate scoring systems for predicting Legionella pneumonia.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Diagnostic accuracies of Ribotest Legionella and Immunocatch Legionella for diagnosing Legionella pneumonia
2. Diagnostic accuracy of Ribotest Legionella for diagnosing Legionella pneumonia due to non-L. pneumophila serogroup 1
Key secondary outcomes
1. Clinical characteristics of Legionella pneumonia due to non-L. pneumophila serogroup 1 (comparison with Legionella pneumonia due to L. pneumophila serogroup 1)
2. Results of treatment for Legionella pneumonia
3. Validation of scoring systems for predicting Legionella pneumonia
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
Hospitalized community-acquired pneumonia patients or nursing and healthcare-associated pneumonia patients over 20 years of age who underwent the Legionella urinary antigen test
Key exclusion criteria
1. Hospital-acquired pneumonia patients
2. Patients suspected to have aspiration pneumonia
3. Patients confirmed to have COVID-19
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Ito |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
ai12306@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Ito |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
ai12306@kchnet.or.jp
Sponsor or person
Institute
Ohara Healthcare Foundation, Kurashiki Central Hospital, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital Ethics Committee
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
086-422-0210
ai12306@kchnet.or.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
静岡市立静岡病院（静岡県）
彦根市立病院（滋賀県）
京都大学医学部附属病院（京都府）
洛和会音羽病院（京都府）
公益財団法人田附興風会医学研究所 北野病院（大阪府）
堺市立総合医療センター（大阪府）
公益財団法人大原記念倉敷中央医療機構 倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 12 | 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 prospective, observational cohort study.
All patients suspected of having Legionella pneumonia in whom the Legionella urinary antigen test is to be performed are enrolled.
Both tests, Ribotest Legionella and Immunocatch Legionella, are performed for all patients.
In all patients, the following clinical data will be investigated:
age, sex, smoking habit, comorbidities, history of hot spring or spa bathing, history of soil exposure, symptoms, oral medicine, vital signs, blood tests, microbiological tests, severity of pneumonia (A-DROP, CURB-65, Pneumonia Severity Index), treatment, prognosis.
Management information
Registered date
| 2021 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049376
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
