UMIN-CTR Clinical Trial

Basic information
Public title	Trends in inpatient antimicrobial use and appropriateness of antimicrobial therapy from 2018 to 2019: a single-center point prevalence survey.
Acronym	A point prevalence survey for inpatient antimicrobial use.
Scientific Title	Trends in inpatient antimicrobial use and appropriateness of antimicrobial therapy from 2018 to 2019: a single-center point prevalence survey.
Scientific Title:Acronym	A point prevalence survey for inpatient antimicrobial use.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the trends in inpatient antimicrobial use and appropriateness of antimicrobial therapy from 2018 to 2019.
Basic objectives2	Others
Basic objectives -Others	To investigate the trends in inpatient antimicrobial use and appropriateness of antimicrobial therapy from 2018 to 2019.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The proportion of antimicrobial drugs that are judged to be used appropriately in all antimicrobial drugs used for treatment. We will compare this outcome with that of the 2018 point prevalence survey of our hospital.
Key secondary outcomes	1) The proportion of patients who receive antimicrobial drugs on the survey date. 2) The proportion of patients who have active healthcare-associated infections. 3) The proportion of cefazolin in all antimicrobial drugs that are used on the survey date.

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 patients hospitalized at 08:00 on the survey day.
Key exclusion criteria	None.
Target sample size	300

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	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 Hospital Organization 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 Hospital Organization Tochigi Medical Center
Institute
Department

Funding Source
Organization	This study is not supported by a specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	275
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 12 Month 18 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 07 Month 11 Day
Date of IRB	2019 Year 08 Month 01 Day
Anticipated trial start date	2019 Year 08 Month 22 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Design:A prospective single-center cross-sectional study. Participants: All hospitalized patients on a survey day. Main outcome measures: The primary outcome is the proportion of antimicrobial drugs that are judged to be appropriately used in all antimicrobial drugs used for treatment. Secondary outcomes are the proportion of patients receiving any antimicrobial agents, the proportion of patients with active healthcare-associated infections, and the proportion of cefazolin in all antimicrobial drugs that are used on the survey day.These outcomes of this study will be compared with those of the 2018 point prevalence study conducted in our hospital.

Management information
Registered date	2019 Year 08 Month 19 Day
Last modified on	2020 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043024