UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036354 |
|---|---|
| Receipt number | R000041408 |
| Scientific Title | Predicting bacteremia using food consumption and shaking chills in outpatients: A multicenter prospective observational study. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/10/01 17:09:53 |
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Basic information
Public title
Predicting bacteremia using food consumption and shaking chills in outpatients: A multicenter prospective observational study.
Acronym
Clinical prediction rule for bacteremia using food consumption and shaking chill
Scientific Title
Predicting bacteremia using food consumption and shaking chills in outpatients: A multicenter prospective observational study.
Scientific Title:Acronym
Clinical prediction rule for bacteremia using food consumption and shaking chill
Region
| Japan |
Condition
Condition
Ptients who underwent blood cultures
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although blood culture tests are needed for the diagnosis of bacteremia, which is one of the serious pathological conditions among infectious diseases, it is required for medical doctor to properly predict bacteremia to avoid the diagnostic error based on the false positive results of blood cultures by contaminating bacteria. So we had reported a simple prediction rule for diagnosis of bacteremia in hospitalized patients that patients did not have bacteremia with 80% or more food consumption and without shaking chills (Komatsu et al JHM 2017). However, because this study required nurse intervention to evaluate food consumption, we must prove that this rule also is useful in outpatients.
Since "food consumption" and "presence or absence of shaking chills" are information obtained from patients by direct interviews,we aimed in this study to prove the usefulness of this predicting rule using "food consumption" and "presence or absence of shaking chills" according to the patient self-assessment obtained by the questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood culture: positive
Key secondary outcomes
vital signs
C-reactive protein
White blood cell counts
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent blood culture tests
Key exclusion criteria
Patients who had the difficulty in communication without any legal person
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Komatsu |
Organization
Juntendo University Nerima Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
177-8521
Address
3-1-10, Takanodai, Nerima-ku, Tokyo, Japan
TEL
+81-3-5923-3111
komaching.1209@drive.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Komatsu |
Organization
Juntendo University Nerima Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
177-8521
Address
3-1-10, Takanodai, Nerima-ku, Tokyo, Japan
TEL
+81-3-5923-3111
Homepage URL
komaching.1209@drive.ocn.ne.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Juntendo University Nerima Hospital
Address
3-1-10, Takanodai, Nerima-ku, Tokyo, Japan
Tel
+81-3-5923-3111
komaching.1209@drive.ocn.ne.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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
250
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delayed research progress because of pandemic of COVID-19
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 | 05 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 31 | Day |
Other
Other related information
We observe whether food consumption and shaking chills according to the patient self-assessment obtained by the questionnaire in outpatients predict bacteremia or not.
Management information
Registered date
| 2019 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041408
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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