UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058353 |
|---|---|
| Receipt number | R000066709 |
| Scientific Title | Development of a diagnostic prediction model for infective endocarditis according to 2023 Duke-International Society for Cardiovascular Infectious disease criteria: A multi-center based observational study |
| Date of disclosure of the study information | 2025/07/03 |
| Last modified on | 2025/07/02 23:19:35 |
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Basic information
Public title
Development of a diagnostic prediction model for infective endocarditis according to 2023 Duke-International Society for Cardiovascular Infectious disease criteria: A multi-center based observational study
Acronym
Development of a diagnostic prediction model for infective endocarditis according to 2023 Duke-International Society for Cardiovascular Infectious disease criteria: A multi-center based observational study
Scientific Title
Development of a diagnostic prediction model for infective endocarditis according to 2023 Duke-International Society for Cardiovascular Infectious disease criteria: A multi-center based observational study
Scientific Title:Acronym
Development of a diagnostic prediction model for infective endocarditis according to 2023 Duke-International Society for Cardiovascular Infectious disease criteria: A multi-center based observational study
Region
| Japan |
Condition
Condition
Infective endocarditis
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Infectious disease | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the cohort for which the model was developed in our previous study, we will find alternative factors to "transfer by ambulance" and reconstruct a predictive model for diagnosis of IE to be diagnosed at 2023 Duke-ISCVID. In addition, we will validate the model using a cohort from four university hospitals.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve, shrinkage coefficient, and stratum-specific likelihood ratio of the reconstructed prediction model for IE among patients with undiagnosed fever
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients 20 years of age or older with International Statistical Classification of Diseases and Related Health Problems-10th Revision code I33.0 for IE or R50.9 for fever of unknown origin recorded during hospitalization.
Key exclusion criteria
Patients with no fever above 37 degree prior to admission; with hospital-onset or referral for valvular surgery after treatment by a previous physician or with non-definite the results of 2023 Duke-ISCVID among patients with I33.0; with a diagnosis confirmed before admission, with R50.9 in which the diagnosis was confirmed prior to admission and in which chest X-ray, blood test, and urinalysis were not performed prior to admission; cases with 2023 Duke-ISCVID of definite with a confirmed diagnosis of noninfectious disease; and cases who declared nonparticipation in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Yamashita |
Organization
Faculty of Medicine, Saga University
Division name
Education and Research Center for Community Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952343238
sy.hospitalist.japan@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Yamashita |
Organization
Faculty of Medicine, Saga University
Division name
Education and Research Center for Community Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952343238
Homepage URL
https://chiken.med.saga-u.ac.jp/
sy.hospitalist.japan@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS KAKENHI grant numbers 23K14739
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
Tel
0952343200 / +81 0952343200
kenkyu-shinsei@ml.cc.saga-u.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
佐賀大学医学部附属病院（佐賀県）/ Saga University Hospital (Saga)
獨協医科大学病院（栃木県）/ Dokkyo University Hospital (Tochigi)
順天堂大学医学部附属順天堂医院（東京）/ Juntendo University Hospital (Tokyo)
東邦大学大森病院（東京）/ Toho University Hospital（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following items of eligible patients were investigated from medical records and referral letters: patient characteristics (age, gender, length of hospital stay, presence or absence of death on discharge, presence or absence of death 30 days after admission, presence or absence of death during hospitalization, presence or absence of transfer by ambulance, presence or absence of antimicrobial therapy prior to obtaining blood culture samples, past history of chronic skin disease, diabetes mellitus, malignancy, steroid use, immunosuppressive drugs, chronic renal failure, and dental visits within 6 months), vital signs on admission (pulse rate, respiratory rate, presence of acute respiratory failure, and consciousness disorder), q-SOFA (quick sequential [sepsis-related] organ failure assessment) score, SIRS (systemic inflammatory response syndrome) score, presence of heart murmur on admission, chest imaging findings on admission (presence of pulmonary edema, pleural effusion), blood tests on admission (white blood cell count, neutrophil fraction, platelet count, albumin level, total bilirubin level, lactate dehydrogenase level, urea nitrogen level, serum creatinine level, C-reactive protein level), and items necessary for evaluation of 2023 Duke-ISCVID.
Management information
Registered date
| 2025 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066709
