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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027577
Receipt No. R000031616
Scientific Title Prospective study of the relationship between patient with high CRP levels and antibiotic therapy
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/31

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Basic information
Public title Prospective study of the relationship between patient with high CRP levels and antibiotic therapy
Acronym Prospective study of the relationship between patient with high CRP levels and antibiotic therapy
Scientific Title Prospective study of the relationship between patient with high CRP levels and antibiotic therapy
Scientific Title:Acronym Prospective study of the relationship between patient with high CRP levels and antibiotic therapy
Region
Japan

Condition
Condition Patients with CRP values greater than 15 mg / L
Classification by specialty
Medicine in general Infectious disease Laboratory medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Antimicrobial drug use rate
Basic objectives2 Others
Basic objectives -Others Factor analysis that did not use antimicrobial drug
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Implementation rate of antibiotic therapy
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
110 years-old >=
Gender Male and Female
Key inclusion criteria CRP > 15 mg/L
in-patient
out-patient
Key exclusion criteria Pediatric patient
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Fukuda Tetsuya
Organization Nishi Saitama Chuo Hospital
Division name Department of Pharmacy
Zip code
Address 2-1671 wakasa, Tokorozawa Saitama 359-1151, Japan.
TEL 04-2948-1111
Email fukudatetsuya-ph@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Fukuda Tetsuya
Organization Nishi Saitama Chuo Hospital
Division name Department of Pharmacy
Zip code
Address 2-1671 wakasa, Tokorozawa Saitama 359-1151, Japan.
TEL 04-2948-1111
Homepage URL
Email fukudatetsuya-ph@umin.ac.jp

Sponsor
Institute Nishi Saitama Chuo Hospital
Institute
Department

Funding Source
Organization Nishi Saitama Chuo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 06 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Implementation rate of antibiotic therapy
28-day mortality
qSOFA
time to antibiotics
duration of antibiotic therapy

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031616

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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