UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications	https://bmjopen.bmj.com/content/10/8/e039329.info
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	2020 Year 08 Month 24 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
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	2021 Year 02 Month 05 Day

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