UMIN-ICDS Clinical Trial

Public title

Reconstruction and validation of a predictive model to estimate the likelihood of infective endocarditis among patients with undiagnosed fever

Acronym

Reconstruction and validation of a predictive model to estimate the likelihood of infective endocarditis among patients with undiagnosed fever

Scientific Title

Reconstruction and validation of a predictive model to estimate the likelihood of infective endocarditis among patients with undiagnosed fever

Scientific Title:Acronym

Reconstruction and validation of a predictive model to estimate the likelihood of infective endocarditis among patients with undiagnosed fever

Region

Japan

Condition

Infective endocarditis/fever of unknown origin

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	Surgery in general
Gastrointestinal surgery	Hepato-biliary-pancreatic surgery	Dermatology
Oto-rhino-laryngology	Urology	Neurosurgery
Plastic surgery	Emergency medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We have previously developed and validated a model for predicting infective endocarditis (IE) among patients with undiagnosed fever using the following simple indicators: transfer by ambulance, presence of cardiac murmur, presence of pleural effusion, neutrofil count(%), and platelet count. As a result, our developed prediction model showed high accuracy. However, the model's factor, "transfer by ambulance," was not an independent predictor in the validation study. In addition, both the development study and the validation study were retrospective studies. Therefore, despite significant differences in univariate analysis, some survey items could not be used for multivariate analysis as factors of the model due to the small number of surveys. The aim of this study is to reconstruct and validate the model for predicting IE. This study will be conducted at the department of general medicine, where more cases with undiagnosed or complicated causes of fever are gathered, in 18 hospitals across Japan (7 university hospitals and 11 city hospitals) with different patient severity and access to hospitals. At the same time, the previously developed and validated predictive model will be also validated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The AUC, shrinkage coefficient, and stratified likelihood ratio of the predictive model for infective endocarditis to be constructed in this study

Key secondary outcomes

1. Sensitivity analysis of the prediction model among patients with native or bioprosthetic valves in this study
2. The AUC, shrinkage coefficient, and stratified likelihood ratio of our previously developed prediction model for infective endocarditis

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

120

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients admitted to the research medical institution for any of the following conditions:
1. Patients admitted to the hospital without identification of a specific cause of fever
2. Patient admitted to the hospital with suspected infective endocarditis
3. Patient admitted to the hospital with a definitive diagnosis of infective endocarditis

Key exclusion criteria

Patients who meet any of the following condition 1 to 4:
1. Patients with identification of a cause of fever other than infective endocarditis prior to admission
2. Patients who did not undergo at least one of the following tests prior to admission: blood test, urinalysis, and chest X-ray
3. Patients who developed fever after 48 hours of admission
4. Patients who did not agree to participate in this study

Target sample size

300

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

Name of contact person

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

Homepage URL

http://chiken.med.saga-u.ac.jp

Email

sy.hospitalist.japan@gmail.com

Institute

Department of General Medicine, Saga University Hospital, Japan

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare in Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Center, 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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2024

Year

04

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

<Survey items>
1. Patient characteristics including patients age, sex, outcome, presence of transfer by ambulance, reason of admission, presence of antibiotic use prior to obtaining blood culture and the types of antibiotics, underlying disease (infective endocarditis, chronic skin disease, replacement of prosthetic valve, history of invasive dental treatments)
2. Vital sign on admission including pulse rate, respiratory rate, systolic blood pressure, diastolic blood pressure, glasgow coma scale, consciousness disorder
3. Physical examinations on admission including cardiac murmur or dental lesions.
4. Presence of pulmonary edema or pleural effusion on admission
5. Laboratory findings on admission;white blood cell count, neutrophil percentage, platelet count, albumin concentration, total bilirubin concentration, LDH concentration, urea nitrogen concentration, creatinine level, and CRP concentration
6. Results of diagnostic criteria for infective endocarditis on admission and discharge
7. Diagnosis of the cause of fever at discharge
8. Presence of valvular heart disease surgery during hospitalization
9. Various test rates: blood culture, echocardiography (transthoracic and transesophageal echocardiography), CT, PET-CT, MRI

Registered date

2023

Year

11

Month

01

Day

Last modified on

2023

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060104