UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041896 |
|---|---|
| Receipt number | R000047758 |
| Scientific Title | Retrospective study about prevalence and virulence of CA-MRSA (community-acquired methicillin-resistant Staphylococcus aureus) in CIED (cardiac implantable electronic device)infection. |
| Date of disclosure of the study information | 2020/09/25 |
| Last modified on | 2020/09/25 15:46:42 |
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Basic information
Public title
Retrospective study about prevalence and virulence of CA-MRSA (community-acquired methicillin-resistant Staphylococcus aureus) in CIED (cardiac implantable electronic device)infection.
Acronym
CA-MRSA CIED infection
Scientific Title
Retrospective study about prevalence and virulence of CA-MRSA (community-acquired methicillin-resistant Staphylococcus aureus) in CIED (cardiac implantable electronic device)infection.
Scientific Title:Acronym
CA-MRSA CIED infection
Region
| Japan |
Condition
Condition
CIED infection
Classification by specialty
| Cardiology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence, patient characteristics, and clinical prognosis of community-acquired MRSA in CIED infection, comparing with hospital-acquired MRSA.
Basic objectives2
Others
Basic objectives -Others
The incidence of acute kidney injury during hospitalization.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of acute kidney injury during hospitalization.
Key secondary outcomes
Mortality rate after lead extraction (30days, 1 year)
The proportion of systemic infection
The duration of antibiotics
The duration of hospitalization
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as CIED infection due to MRSA
Key exclusion criteria
Patients without enough clinical data for analysis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Fukunaga |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1 Asano kokurakita-ku, Kitakyushu, Fukuoka, Japan
TEL
093-511-2000
masato_f0728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Fukunaga |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1 Asano kokurakita-ku, Kitakyushu, Fukuoka, Japan
TEL
093-511-2000
Homepage URL
masato_f0728@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology, Kokura Memorial Hospital
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
Tokyo Medical and Dental University, Takaishi Fujii Cardio Vascular Hospital, Shonan Kamakura General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Kokura Memorial Hospital
Address
3-2-1 Asano kokurakita-ku, Kitakyushu, Fukuoka, Japan
Tel
093-511-2000
rinsyo@kokurakinen.or.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
小倉記念病院(福岡県), 東京医科歯科大学(東京都), 高石藤井心血管病院(大阪府), 湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 25 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics and clinical prognosis will be investigated, comparing CA-MRSA with HA-MRSA.
Management information
Registered date
| 2020 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047758
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
