Unique ID issued by UMIN | UMIN000052976 |
---|---|
Receipt number | R000060438 |
Scientific Title | Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens |
Date of disclosure of the study information | 2023/12/06 |
Last modified on | 2024/12/17 15:50:07 |
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Japan |
none
Adult |
Others
NO
This study aims to compare the detection sensibility of four methods for collecting respiratory infectious pathogens from Japanese patients with respiratory infectious diseases. Four types of specimens (nasopharyngeal swabs, nasal swabs, nasal discharge, and saliva) will be collected from study subjects immediately after the onset of common cold-like symptoms and be subjected to multiplex PCR testing for more than 10 kinds of pathogens that cause respiratory infections. For specimens in which the pathogens are detected, the detection sensibility will be compared. In future vaccine development, the results of this study will help in selecting a highly sensitive detection method suitable for Japanese patients with respiratory infectious diseases in disease prevention studies.
Others
not applicable
Detection sensibility in various specimen collection methods
Observational
50 | years-old | <= |
Not applicable |
Male and Female
<Cohort A>
1.Subjects who have given written consent.
2.Japanese males or females aged 50 years or older at the time of informed consent.
3.Subjects who are able to call the study site immediately when they experience at least two of common cold-like symptoms, to collect the specimen by themselves within 6 hours from the time they experience the second symptoms, and to visit the study site on the designated date (within 72 hours from the time they experience the second symptoms).
Common cold-like symptoms are:
Nasal discharge, nasal congestion, pharyngeal pain, cough, wheezing, sputum, shortness of breath, or body temperature of 37.5 degrees or higher.
4.Subjects who are able to visit the study site within the designated period (3, 6, 9 and 12 months after the consent, and the end visit). When the number of subjects reaches the target, the study will be terminated early. In such a case, the end visit will be performed within 30 days after the termination date, and the three-monthly visits mentioned above will no longer be required.
<Cohort B>
1.Subjects who have given written consent.
2.Japanese males or females aged 50 years or older at the time of informed consent.
3.Subjects who have at least two of common cold-like symptoms and are able to visit the study site within 72 hours of the onset of the second symptoms.
Common cold-like symptoms are:
Nasal discharge, nasal congestion, pharyngeal pain, cough, wheezing, sputum, shortness of breath, or body temperature of 37.5 degrees or higher.
Subjects who are assessed as ineligible for the study by the principal investigator or sub-investigator.
1000
1st name | Hidetoshi |
Middle name | |
Last name | Furuie |
Medical Corporation Heishinkai OPHAC Hospital
none
532-003
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
06-6395-9000
hidetoshi.furuie@heishinkai.com
1st name | Hidetoshi |
Middle name | |
Last name | Furuie |
Medical Corporation Heishinkai OPHAC Hospital
none
532-0003
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
06-6395-9000
hidetoshi.furuie@heishinkai.com
others
Others
Profit organization
Japan
InCROM Inc.
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
06-6395-9000
sumiko.kawamoto@heishinkai.com
NO
2023 | Year | 12 | Month | 06 | Day |
Unpublished
No longer recruiting
2023 | Year | 11 | Month | 27 | Day |
2023 | Year | 12 | Month | 01 | Day |
2023 | Year | 12 | Month | 15 | Day |
2025 | Year | 02 | Month | 28 | Day |
none
2023 | Year | 12 | Month | 01 | Day |
2024 | Year | 12 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060438