UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037720 |
|---|---|
| Receipt number | R000043024 |
| Scientific Title | Trends in inpatient antimicrobial use and appropriateness of antimicrobial therapy from 2018 to 2019: a single-center point prevalence survey. |
| Date of disclosure of the study information | 2019/08/19 |
| Last modified on | 2020/02/01 23:49:38 |
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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
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
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
National Hospital Organization Tochigi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043024
