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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044061
Receipt No. 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 2021/04/28

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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
Email 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
Email yanohisa@naramed-u.ac.jp

Sponsor
Institute The Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology
Institute
Department

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
Email 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

Other
Other related information surveillance

Management information
Registered date
2021 Year 04 Month 28 Day
Last modified on
2021 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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