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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036354
Receipt No. 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 2020/03/30

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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
Email 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
Email komaching.1209@drive.ocn.ne.jp

Sponsor
Institute Juntendo University Nerima Hospital
Institute
Department

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
Email 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 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
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
Date trial data considered complete
Date analysis concluded

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
2020 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041408

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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