UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056185 |
|---|---|
| Receipt number | R000064203 |
| Scientific Title | Evaluation of rapid antigen tests for five respiratory pathogens |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2025/09/09 22:17:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of rapid antigen tests for five respiratory pathogens
Acronym
Evaluation of rapid antigen tests for respiratory infection
Scientific Title
Evaluation of rapid antigen tests for five respiratory pathogens
Scientific Title:Acronym
Evaluation of rapid antigen tests for respiratory infection
Region
| Japan |
Condition
Condition
respiratory infection
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate diagnostic performance of rapid antigen tests for five respiratory pathogens
Basic objectives2
Others
Basic objectives -Others
To evaluate diagnostic performance of rapid antigen tests for five respiratory pathogens
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity and specificity of rapid antigen tests compared with polymerase chain reaction (PCR) tests among children with respiratory infection
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with respiratory symptoms requiring swabbing for microbiological tests
Key exclusion criteria
Not agreeable to participate to the study
Had the same test within 30 days in the study center
Lack of sufficient sample for the testing
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Yoshida |
Organization
Nara Prefecture General Medical Center
Division name
Pediatrics
Zip code
630-8581
Address
2-897-5 Shichijo West
TEL
0742466001
drsayaka@nara-hp.jp
Public contact
Name of contact person
| 1st name | Taito |
| Middle name | |
| Last name | Kitano |
Organization
Nara Prefecture General Medical Center
Division name
Pediatrics
Zip code
630-8581
Address
2-897-5 Shichijo West
TEL
0742466001
Homepage URL
taito.kitano0110@gmail.com
Sponsor or person
Institute
Nara Prefecture General Medical Center
Institute
Department
Personal name
Funding Source
Organization
TAUNS LABORATORIES, INC
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
Nara Prefecture General Medical Center
Address
Shichijo West 2-897-5
Tel
0742466001
tkitano@nara-hp.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
| 2024 | Year | 12 | Month | 15 | 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
| 2024 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Specimen collection and antigen qualitative test kits and PCR testing should be carried out as follows.
(1) In the paediatric outpatient department and ER at Nara General Medical Centre, tests using the Tauns Antigen Qualitative Test Kit will be conducted in addition to the usual test (PCR method) as part of testing for respiratory tract infections in paediatric patients under 18 years of age. For the collection of specimens for the Townes Antigen Qualitative Test Kit, two separate nasopharyngeal swabs will be collected after written consent is obtained on the consent form (PCR method for the usual test and antigen qualitative test kit, two bottles in total).
(2) Residual specimens of the PCR method used in the normal medical examination are sent to Tauns Inc., and then the copy number is determined by real time PCR testing.
(3) At Nara Prefectural General Medical Centre, the results of the PCR test and the results of the Tauns Antigen Qualitative Test Kit will be compared to see the positive and negative concordance rates. FilmArray is used for the PCR test.
(4) Tauns carries out a real time PCR test on the positive specimens to determine the copy number.
The real time PCR test uses the Infectious Diseases Research Institute method. The final results from Tauns Inc. are sent to Nara Prefectural General Medical Centre via electronic media, and the results of the antigen qualitative test kit and real time PCR test are analysed at Nara Prefectural General Medical Centre.
Management information
Registered date
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064203
