UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence of antimicrobial use in acute care hospitals: a multicenter prevalence survey in Japan.
Acronym	Prevalence of antimicrobial use in acute care hospitals
Scientific Title	Prevalence of antimicrobial use in acute care hospitals: a multicenter prevalence survey in Japan.
Scientific Title:Acronym	Prevalence of antimicrobial use in acute care hospitals
Region	Japan

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

Objectives
Narrative objectives1	To determine the prevalence of antimicrobial use and health care-associated infections.
Basic objectives2	Others
Basic objectives -Others	1) To determine the prevalence of antimicrobial use and describe the rationale for antimicrobial use 2) To determine the prevalence of active health care-associated infections
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Antimicrobial use prevalence
Key secondary outcomes	Prevalence of active health care-associated infections

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 hospitalized patients at a survey
Key exclusion criteria	None
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Junpei Middle name Last name Komagamine
Organization	National Hospital Organization Tochigi Medical Center
Division name	Internal Medicine
Zip code	3208580
Address	1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL	0286225241
Email	junpei0919@yahoo.co.jp

Public contact
Name of contact person	1st name Junpei Middle name Last name Komagamine
Organization	National Hospital Organization Tochigi Medical Center
Division name	Internal Medicine
Zip code	3208580
Address	1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL	0286225241
Homepage URL
Email	junpei0919@yahoo.co.jp

Sponsor
Institute	National Hospital Organization Tochigi Medical Center
Institute
Department

Funding Source
Organization	No funding sources
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Saiseikai Utsunomiya Hospital
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（栃木県）、済生会宇都宮病院（栃木県）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://bmjopen.bmj.com/content/9/6/e027604
Number of participants that the trial has enrolled	820
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 06 Month 28 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	2018 Year 07 Month 27 Day
Date of IRB	2018 Year 07 Month 27 Day
Anticipated trial start date	2018 Year 08 Month 02 Day
Last follow-up date	2018 Year 10 Month 02 Day
Date of closure to data entry	2018 Year 10 Month 02 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	One-day prevalence surveys will be conducted in two acute care hospitals between July and December 2018. All patients hospitalized at 8 a.m. in a survey will be included. We will collect information on patients' characteristics and antimicrobial agents used for patients from electric medical records.

Management information
Registered date	2018 Year 07 Month 31 Day
Last modified on	2019 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038281