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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039360
Receipt No. R000044884
Scientific Title Prevalence of antimicrobial use among ambulatory care visits in Japan: a prospective multicentre cross-sectional study.
Date of disclosure of the study information 2020/02/01
Last modified on 2020/03/02

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Basic information
Public title Prevalence of antimicrobial use among ambulatory care visits in Japan: a prospective multicentre cross-sectional study.
Acronym Prevalence of antimicrobial use among ambulatory care visits in Japan.
Scientific Title Prevalence of antimicrobial use among ambulatory care visits in Japan: a prospective multicentre cross-sectional study.
Scientific Title:Acronym Prevalence of antimicrobial use among ambulatory care visits in Japan.
Region
Japan

Condition
Condition Infectious disease
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the rates of outpatient antimicrobial use and the rationale for antimicrobial use.
Basic objectives2 Others
Basic objectives -Others To investigate appropriateness of antimicrobial drug use in ambulatory care visits
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is the proportion of ambulatory visits with antimicrobial drug prescriptions.
Key secondary outcomes The secondary outcomes are reasons for antimicrobial drug use and the proportion of inappropriate antimicrobial use in all antimicrobial drugs used for treatment.

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 All ambulatory visits during the study period will be included.
Key exclusion criteria Visits resulting in hospital admission and regularly scheduled visits are excluded.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Junpei
Middle name
Last name Komagamine
Organization National Organization Hospital Tochigi Medical Center
Division name Department of Internal Medicine
Zip code 3208580
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, Japan
TEL 0286225241
Email jkomagamine@tochigi-mc.jp

Public contact
Name of contact person
1st name Junpei
Middle name
Last name Komagamine
Organization National Organization Hospital Tochigi Medical Center
Division name Department of Internal Medicine
Zip code 3208580
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, Japan
TEL 0286225241
Homepage URL
Email jkomagamine@tochigi-mc.jp

Sponsor
Institute National Organization Hospital Tochigi Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Tochigi Medical Center
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, Japan
Tel 0286225241
Email atamura@tochigi-mc.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 独立行政法人国立病院機構栃木医療センター、独立行政法人国立病院機構東京医療センター、独立行政法人国立病院機構長崎医療センター

Other administrative information
Date of disclosure of the study information
2020 Year 02 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 1952
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 No longer recruiting
Date of protocol fixation
2019 Year 12 Month 06 Day
Date of IRB
2019 Year 11 Month 11 Day
Anticipated trial start date
2020 Year 02 Month 02 Day
Last follow-up date
2020 Year 02 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To determine the rates of outpatient antimicrobial use and the rationale for antimicrobial use, a prospective multi-centre observational study will be conducted in three acute care hospitals in Japan. All consecutive ambulatory visits from 2 February 2020 will be included. We will included more than 500 visits per hospital. Visits resulting in hospital admission and regularly scheduled visits are excluded. The primary outcome is the proportion of ambulatory visits with antimicrobial drug prescriptions. The secondary outcomes are reasons for antimicrobial drug use and the proportion of inappropriate antimicrobial use in all antimicrobial drugs used for treatment.

Management information
Registered date
2020 Year 02 Month 01 Day
Last modified on
2020 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044884

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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