UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051931 |
|---|---|
| Receipt number | R000059251 |
| Scientific Title | Evaluation of antimicrobial and surgical treatment for MRSA (methicillin-resistant Staphylococcus aureus) endocarditis. |
| Date of disclosure of the study information | 2023/08/17 |
| Last modified on | 2023/08/17 14:15:27 |
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Basic information
Public title
Evaluation of antimicrobial and surgical treatment for MRSA (methicillin-resistant Staphylococcus aureus) endocarditis.
Acronym
Evaluation of antimicrobial and surgical treatment for MRSA (methicillin-resistant Staphylococcus aureus) endocarditis.
Scientific Title
Evaluation of antimicrobial and surgical treatment for MRSA (methicillin-resistant Staphylococcus aureus) endocarditis.
Scientific Title:Acronym
Evaluation of antimicrobial and surgical treatment for MRSA (methicillin-resistant Staphylococcus aureus) endocarditis.
Region
| Japan |
Condition
Condition
Infective endocarditis (IE) due to MRSA
Classification by specialty
| Cardiology | Infectious disease | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the characteristics of patients with MRSA IE in Japan, antimicrobial therapy, and to determine the actual rate of surgical treatment and patient prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day and in-hospital mortality
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a definite diagnosis of MRSA-IE from January 2015 to April 2019 were included.
Key exclusion criteria
-Patients under the age of 16.
-Patients with Healed IE.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Mitsutake |
Organization
Saitama Medical University International Medical Center
Division name
Division of Infectious Diseases and Infection Control
Zip code
3501298
Address
1397-1, Yamane, Hidaka City, Saitama, Japan
TEL
0429844111
kmitsuta@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Shinya |
Organization
Saitama Medical University International Medical Center
Division name
Infection Control Center
Zip code
3501298
Address
1397-1, Yamane, Hidaka City, Saitama, Japan
TEL
0429844111
Homepage URL
ns92671@5931.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International 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
Saitama Medical University International Medical Center IRB
Address
1397-1, Yamane, Hidaka City, Saitama, Japan
Tel
0429844523
chikens@saitama-med.ac.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
| 2023 | Year | 08 | Month | 17 | 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
65
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-Study design: observational study (multi-institution study)
-Research period: Mar.6,2019 to Dec.31,2023
-Survey items:
Patient characteristics (age, sex, comorbidities, clinical complications, MRSA carriage, portal of entry)
Diagnosis (nosocomial or community-acquired, infected lesion, echocardiographic findings, MIC, duration of bacteremia)
Treatment (surgery performed or not, timing of surgery, antimicrobial selection, duration of antimicrobial therapy)
Prognosis (30days and in-hospital mortality)
Management information
Registered date
| 2023 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059251
| 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 |
