UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047819 |
|---|---|
| Receipt number | R000054506 |
| Scientific Title | Exploratory research on pharyngeal examination in patients with group A Streptococcus pharyngitis |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/05/27 08:35:10 |
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Basic information
Public title
Exploratory research on pharyngeal examination in patients with group A Streptococcus pharyngitis
Acronym
Exploratory research on pharyngeal examination in patients with group A Streptococcus pharyngitis
Scientific Title
Exploratory research on pharyngeal examination in patients with group A Streptococcus pharyngitis
Scientific Title:Acronym
Exploratory research on pharyngeal examination in patients with group A Streptococcus pharyngitis
Region
| Japan |
Condition
Condition
Group A Streptococcus pharyngitis
Classification by specialty
| Medicine in general | Infectious disease | Pediatrics |
| Oto-rhino-laryngology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to collect and examine pharyngeal images, medical interviews, and infectious disease test results in patients with suspected streptococcal infections.
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharyngeal images, medical interviews, and infectious disease test results in patients with suspected streptococcal infections
Key secondary outcomes
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit research institutes with complaints of fever and/or pharyngeal symptoms, and who meet all of the following criteria:
Patients who provide written informed consent
Patients aged over 3 years
Patients with suspected group A Streptococcus pharyngitis who are scheduled for a streptococcal antigen test
Key exclusion criteria
Patients with tooth mobility
Patients who have severe oral lesions in areas where the research equipment will be placed
Patients with severe nausea
Patients who have difficulty opening the mouth wide enough for research equipment insertion
Patients with impaired consciousness or respiratory failure
Patients who are scheduled to participate in other clinical trials or clinical research(excluding post-marketing surveillance)
Patients who are unable to comply with the research protocol and be followed up (due to mental, familial, social, geographical, or other reasons)
Children who clearly have an inadequate understanding of this study
Any other patient judged to be inappropriate by the investigator
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Yurika |
| Middle name | |
| Last name | Kimura |
Organization
Tokyo Metropolitan Ebara Hospital
Division name
Otolaryngology
Zip code
145-0065
Address
4-5-10 Higashiyukigaya, Ota-ku, Tokyo 146-0065 Japan
TEL
03-5734-8000
yurika_kimura@tokyo-hmt.jp
Public contact
Name of contact person
| 1st name | Yurika |
| Middle name | |
| Last name | Kimura |
Organization
Tokyo Metropolitan Ebara Hospital
Division name
Otolaryngology
Zip code
145-0065
Address
4-5-10 Higashiyukigaya, Ota-ku, Tokyo 146-0065 Japan
TEL
03-5734-8000
Homepage URL
yurika_kimura@tokyo-hmt.jp
Sponsor or person
Institute
Tokyo Metropolitan Ebara Hospital
Institute
Department
Personal name
Funding Source
Organization
Aillis, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Ebara Hospital Ethics Committee
Address
4-5-10 Higashiyukigaya, Ota-ku, Tokyo 146-0065 Japan
Tel
03-5734-8000
ijika-rinri@tokyo-hmt.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
| 2022 | Year | 06 | Month | 01 | 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
74
Results
Antigen rapid test results
GAS Positive ; 27
GAS Negative ; 47
Results date posted
| 2023 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective non-interventional observational study
Management information
Registered date
| 2022 | Year | 05 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054506
