UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044061 |
|---|---|
| Receipt number | R000050303 |
| Scientific Title | The seventh nationwide surveillance of six otorhinolaryngological infectious diseases and the antimicrobial susceptibility patterns of the isolated pathogens in Japan conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology. |
| Date of disclosure of the study information | 2021/04/28 |
| Last modified on | 2024/03/12 14:47:04 |
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Basic information
Public title
The seventh nationwide surveillance of six otorhinolaryngological infectious diseases and the antimicrobial susceptibility patterns of the isolated pathogens in Japan conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology.
Acronym
The seventh nationwide surveillance of six otorhinolaryngological infectious diseases and the antimicrobial susceptibility patterns of the isolated pathogens in Japan
Scientific Title
The seventh nationwide surveillance of six otorhinolaryngological infectious diseases and the antimicrobial susceptibility patterns of the isolated pathogens in Japan conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology.
Scientific Title:Acronym
The seventh nationwide surveillance of six otorhinolaryngological infectious diseases and the antimicrobial susceptibility patterns of the isolated pathogens in Japan
Region
| Japan |
Condition
Condition
otorhinolaryngological infectious diseases
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the susceptibility of various antimicrobial agents to causative organisms isolated from patients with four otorhinolaryngological diseases.
Basic objectives2
Others
Basic objectives -Others
To monitor the prevalence of antibiotic-resistant bacteria
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Susceptibility of isolated causative strains to various antibiotics
Key secondary outcomes
Isolation frequency of antimicrobial resistant bacteria and
analysis by area and facility
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute otitis media (under six years old), chronic otitis media, acute tonsillitis, and peritonsillar abscess (over 20 years old) who were medically diagnosed at the participating facilities
Key exclusion criteria
A patient who is deemed inappropriate by the researchers
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hisakazu |
| Middle name | |
| Last name | Yano |
Organization
Nara Medical University
Division name
Department of Microbiology and Infectious Diseases
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
yanohisa@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisakazu |
| Middle name | |
| Last name | Yano |
Organization
Nara Medical University
Division name
Department of Microbiology and Infectious Diseases
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
http://www.3ssp.jp
yanohisa@naramed-u.ac.jp
Sponsor or person
Institute
The Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology
Institute
Department
Personal name
Funding Source
Organization
The Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.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
| 2021 | Year | 04 | 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
| 2020 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
surveillance
Management information
Registered date
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050303
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
