UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045814 |
|---|---|
| Receipt number | R000052303 |
| Scientific Title | Prevalence of antimicrobial drug use and concurrent bacterial infections in hospitalized COVID-19 patients. |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2023/10/14 19:38:17 |
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Basic information
Public title
Prevalence of antimicrobial drug use and concurrent bacterial infections in hospitalized COVID-19 patients.
Acronym
Prevalence of antimicrobial drug use and concurrent bacterial infections in hospitalized COVID-19 patients.
Scientific Title
Prevalence of antimicrobial drug use and concurrent bacterial infections in hospitalized COVID-19 patients.
Scientific Title:Acronym
Prevalence of antimicrobial drug use and concurrent bacterial infections in hospitalized COVID-19 patients.
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 drug use and the proportion of patients who had microbiologically confirmed concurrent infection during hospitalization
Basic objectives2
Others
Basic objectives -Others
N.A.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Prevalence of antimicrobial drug use during hospitalization
2. Proportion of patients who had microbiologically confirmed concurrent infection during hospitalization
Key secondary outcomes
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 consecutive symptomatic COVID-19 patients who are confirmed by SARS-CoV-2 nucleic acid or antigen tests and who are hospitalized in our hospital
Key exclusion criteria
Patients who are transferred to other hospitals for intensive care
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
NHO Tochigi Medical Center
Division name
Internal Medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya
TEL
028-622-5241
jkomagamine@tochigi-mc.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
NHO Tochigi Medical Center
Division name
Internal medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya
TEL
028-622-5241
Homepage URL
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
NHO 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
NHO Tochigi Medical Center
Address
1-10-37, Nakatomatsuri, Utsunomiya
Tel
028-622-5241
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
| 2021 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1056
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study will be conducted by using electronic medical records. All consecutive symptomatic COVID-19 patients who were confirmed by SARS-CoV-2 nucleic acid or antigen tests and who were hospitalized in our hospital from November 1, 2020, to October 9, 2021, will be included. The aim of this research is to determine the prevalence of antimicrobial drug use and the proportion of patients who had microbiologically confirmed concurrent infection during hospitalization.
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052303
