UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047291 |
|---|---|
| Receipt number | R000053934 |
| Scientific Title | Serial analysis of urinary antigen levels and urinary antigen test kit results in Legionella pneumonia patients |
| Date of disclosure of the study information | 2022/03/28 |
| Last modified on | 2023/02/08 11:48:41 |
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Basic information
Public title
Serial analysis of urinary antigen levels and urinary antigen test kit results in Legionella pneumonia patients
Acronym
Analysis of urinary antigen levels and urinary antigen test kit results in Legionella pneumonia
Scientific Title
Serial analysis of urinary antigen levels and urinary antigen test kit results in Legionella pneumonia patients
Scientific Title:Acronym
Analysis of urinary antigen levels and urinary antigen test kit results in 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 investigate the duration of positive results with urinary antigen test kits (Ribotest Legionella and Immunocatch Legionella) in Legionella pneumonia patients.
Basic objectives2
Others
Basic objectives -Others
To serially compare urinary antigen test kit results (Ribotest Legionella and Immunocatch Legionella) with LPS antigen levels and L7/L12 antigen levels in urine in Legionella pneumonia patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Diagnostic accuracies of Ribotest Legionella and Immunocatch Legionella for diagnosing Legionella pneumonia.
2. Time course of changes in urinary antigen test kit (Ribotest Legionella and Immunocatch Legionella) results.
Key secondary outcomes
1. Time course of changes in LPS antigen levels and L7/L12 antigen levels in urine, and correlation between LPS and L7/L12 antigen levels and urinary antigen test kit (Ribotest Legionella and Immunocatch Legionella) results.
2. Analysis of false negative cases with urinary antigen test kits.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hospitalized community-onset pneumonia patients over 15 years of age who were diagnosed with Legionella pneumonia.
2. Patients who are able to collect urine samples.
Key exclusion criteria
Hospital-acquired pneumonia patients.
Target sample size
20
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
KYOKUTO PHARMACEUTICAL INDUSTRIAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
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
| 2022 | Year | 03 | Month | 28 | 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
| 2022 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | 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 hospitalized community-onset pneumonia patients diagnosed with Legionella pneumonia will be enrolled.
Patients who satisfy at least one of the following items are defined as having Legionella pneumonia: 1. positive urinary antigen test kit (Ribotest Legionella and/or Immunocatch Legionella) result, 2. identification of Legionella species in respiratory specimens, 3. identification of Legionella species genes in respiratory specimens.
In enrolled patients, urinary antigen test kit levels (Ribotest Legionella and Immunocatch Legionella), and LPS antigen levels and L7/L12 antigen levels in urine will be measured according to the following schedule: the day of diagnosis (1st day), daily from the 2nd to the 7th day, and on the 10th day (9th-11th day), 14th day (12th-16th day), 21st day (19th-23rd day) and 28th day (26th-30th day) from diagnosis. If the patient is discharged early, urine samples will be collected as frequently as possible. Urine samples that are collected in outpatients are also acceptable.
Urine samples will be sent to Kyokuto Pharmaceutical Industrial Co., Ltd. and urinary antigen tests (Ribotest Legionella and Immunocatch Legionella), and measurement of LPS and L7/L12 antigen levels will be performed at Kyokuto Pharmaceutical Industrial Co., Ltd.
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 medications, vital signs, blood tests, chest radiography, chest computed tomography, microbiological tests, severity of pneumonia (CURB-65, Pneumonia Severity Index), treatment and prognosis.
Management information
Registered date
| 2022 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053934
