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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000041344
Receipt No. R000047202
Scientific Title Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study
Date of disclosure of the study information 2020/08/07
Last modified on 2021/08/15

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Basic information
Public title Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study
Acronym Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study
Scientific Title Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study
Scientific Title:Acronym Clinical prediction rule of infective endocarditis
Region
Japan

Condition
Condition Infective endocarditis/fever of unknown origin
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Cardiology
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Neurology Clinical immunology
Infectious disease Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Dermatology Urology Emergency medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop clinical prediction rule of definite IE in modified Dukes criteria for fever of unknown origin, comparing inpatients with IE and inpatients with fever of unknown origin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Modified Dukes criteria
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 1. Patients with ICD-10 code of IE (I-330) admitted to our hospital from September 2007 to August 2017
3. Patients with ICD-10 code of fever of unknown origin (R-50-9) admitted to our hospital from January 2015 to December 2017
Key exclusion criteria 1. Non-hospitalization
2. Without fever before hospitalization
3. Of I-330 patients, nosocomial onset patients or non-definite IE in modified Dukes criteria
4. Of patients with I-330, patients with referral for valve surgery after treatment in previous hospital
5. Of patients with R-50-9, patients with identifiable fever origin before hospitalization
6. Those who have announced that they will not participate in the research
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shun
Middle name
Last name Yamashita
Organization Saga University Hospital
Division name Department of General Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952343238
Email sy.hospitalist.japan@gmail.com

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Tago
Organization Saga University Hospital
Division name Department of General Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952343238
Homepage URL https://www.hospital.med.saga-u.ac.jp/chiken/patient/open/general.html
Email tagomas@cc.saga-u.ac.jp

Sponsor
Institute Department of General Medicine, Saga University Hospital, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of General Medicine, Saga University Hospital
Address 5-1-1 Nabeshima, Saga 849-8501, Japan
Tel 0952-34-3400
Email 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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 144
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
2020 Year 06 Month 20 Day
Date of IRB
2020 Year 07 Month 22 Day
Anticipated trial start date
2020 Year 07 Month 22 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 10 Month 26 Day
Date analysis concluded
2020 Year 10 Month 26 Day

Other
Other related information Three doctors of the general medical department of our hospital checked the referral letter from the previous doctor and the medical information in the electronic medical record, and collected the data on potentially eligible patients. The survey items are age, sex, length of hospital stay, presence of death within 30 days after admission, presence of death during hospitalization, presence of emergency transportation, presence of pre-hospital antibiotics, and symptoms within 2 months of visiting our hospital ( respiratory distress, consciousness disorder, paralysis, weakness, general malaise, back pain, arthralgia), comorbidities and their nature (chronic skin disease, diabetes, malignant tumor, administration of steroids or immunosuppressants, chronic renal failure, vasculitis, history of a dental clinic visit within the past six months, history of invasive dental treatments within the past six months), Vital sign at admission (pulse rate, respiratory rate, systolic blood pressure, diastolic blood pressure, SpO2, consciousness disorder, oxygen use, oxygen dose), physical examinations on admission (cardiac murmur or dental lesions), laboratory findings on admission, and chest imaging findings within 14 days after admission (pulmonary edema or pleural effusion).

Management information
Registered date
2020 Year 08 Month 07 Day
Last modified on
2021 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/05/13 IE予測;Data base(UMIN登録用).xlsx


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