UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054580 |
|---|---|
| Receipt number | R000062368 |
| Scientific Title | Development of a prediction model of infectious disease among patients with undiagnosed fever: A single-hospital-based retrospective study |
| Date of disclosure of the study information | 2024/06/05 |
| Last modified on | 2026/01/01 21:12:25 |
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Basic information
Public title
Development of a prediction model of infectious disease among patients with undiagnosed fever: A single-hospital-based retrospective study
Acronym
Development of a prediction model of infectious disease among patients with undiagnosed fever: A single-hospital-based retrospective study
Scientific Title
Development of a prediction model of infectious disease among patients with undiagnosed fever: A single-hospital-based retrospective study
Scientific Title:Acronym
Development of a prediction model of infectious disease among patients with undiagnosed fever: A single-hospital-based retrospective study
Region
| Japan |
Condition
Condition
fever of unknown origin
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Hematology and clinical oncology |
| Neurology | Clinical immunology | Infectious disease |
| Dermatology | Urology | Emergency medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Serum ferritin levels may show a possible disease specificity depending on their value and may be useful in differentiating the causative disease of fever. Indeed, one report has shown that the AUC of serum ferritin levels on admission to hospital for infectious diseases was 0.75. However, another report has shown that the AUC of serum ferritin levels alone for infectious diseases was as low as 0.64. These suggest that serum ferritin levels alone may not be sufficient for predicting infectious diseases. Several models have been proposed to differentiate infectious and non-infectious diseases as causes of unknown fever. One of these models includes serum ferritin levels as a predictive factor. However, many other factors are required, such as gender, shivering chills, LDH, procalcitonin levels, ANA, presence of lymphadenopathy or pleural ascites, hepatosplenomegaly and interferon gamma release assay, which do not provide rapid results. Another model consists of three factors: serum amyloid protein levels and neutrophil percentage in addition to serum ferritin levels. However, serum amyloid protein levels is tested less frequently in routine practice in Japan. Therefore, it is desirable to develop a simple model with items that can be more easily tested and rapidly identified. In the present study, we aimed to develop a model for predicting infectious diseases using only blood test items commonly measured on admission, including serum ferritin levels.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The AUC, shrinkage coefficient and stratified likelihood ratio of the predictive model for infectious diseases to be constructed in this study.
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who were admitted to Saga University Hospital between 1 January 2013 and 31 December 2022 and had ICD-10 code R-50-9 (fever of unknown cause) during their hospital admission were included.
Key exclusion criteria
-Cases in which serum ferritin levels have not been measured from the day before admission to three days after admission
-Cases in which the diagnosis was definitly confirmed before admission
-Cases in which chest radiographs, blood tests and urinalysis were not performed at the time of admission
Target sample size
143
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
0952342249
sy.hospitalist.japan@gmail.com
Public contact
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
sy.hospitalist.japan@gmail.com
Sponsor or person
Institute
Department of General Medicine, Saga University Hospital, Japan
Institute
Department
Personal name
Funding Source
Organization
Japanse Society of Hospital General Medicine
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
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
Tel
0952343400
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
| 2024 | Year | 06 | Month | 05 | 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
143
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
| 2024 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 03 | 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
| 2026 | Year | 01 | Month | 30 | Day |
Other
Other related information
The following will be investigated in the target cases: age; sex; admission and discharge dates; number of days in hospital; whether there was an emergency transfer; mortality rate during hospitalisation; rate of various tests performed for diagnosis (blood culture, sputum culture, spinal fluid culture, echocardiography, head CT scan, head MRI scan, chest X-ray, chest contrast CT scan, spine MRI, upper gastrointestinal endoscopy, lower gastrointestinal endoscopy, cytology, pathology, determination of TB interferon-gamma and syphilis test, beta-D glucan levels); blood tests on admission (white blood cell count, neutrophil fraction, platelet count, C-reactive protein, D dimmer, FDP, lactate dehydrogenase level, Albumin level, Total bilirubin level, aspartate aminotransferase level, alanine aminotransferase level, blood urea nitrogen level, creatinine level, Sodium level (blood urea nitrogen level, creatinine level, Sodium level, Potasium level, Chrolide level, serum ferritin level). The proportion of antimicrobials administered prior to blood cultures being taken should also be investigated, unless the patient has been taking antimicrobials for a long period of time, e.g. for chronic bronchitis. Neutrophil fractions are included in the survey as they have been reported to be useful in previous studies. For serum ferritin levels, measurements from the day before admission to within three days of admission should be adopted, as it is difficult to measure serum ferritin levels at night and on holidays. Factors affecting serum ferritin levels, such as the presence or absence of iron administration and transfusion of concentrated red blood cells, will also be investigated.
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062368
