UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039360 |
|---|---|
| Receipt number | 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 | 2021/02/05 06:39:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
National Organization Hospital Tochigi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
