UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015333 |
|---|---|
| Receipt number | R000017829 |
| Scientific Title | Clinical evaluation study of 'DiagnoSep', the bacterial detection kit |
| Date of disclosure of the study information | 2014/10/03 |
| Last modified on | 2014/10/03 07:32:54 |
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Basic information
Public title
Clinical evaluation study of 'DiagnoSep', the bacterial detection kit
Acronym
Evaluation study of the bacterial detection kit
Scientific Title
Clinical evaluation study of 'DiagnoSep', the bacterial detection kit
Scientific Title:Acronym
Evaluation study of the bacterial detection kit
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Infectious disease | Laboratory medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a bacterial detection kit in peripheral blood leukocytes of patients with suspected sepsis, 'DiagnoSep' (Fuso Pharmaceutical Industries, Ltd.) was developed by combining PCR assay and nucleic acid lateral flow method. The aim of this study is to evaluate the clinical utility of 'DiagnoSep'.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between sepsis and the results of DiagnoSep.
Key secondary outcomes
The relationship between sepsis, bacterial infection, and the results obtained from DiagnoSep and HybriSep.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with suspected sepsis.
As follows, patient exhibits two or more of the following criteria;
Body temperature: >38C or <36C
Heart rate: 90 beats/min
Respiration rate: >20 breaths/min or PaCO2 < 32 mm Hg
White blood cell count: >12,000/uL, <4000/uL, or > 10% immature forms
, and suspected or proven infection.
Key exclusion criteria
White blood cell count: <3,000/uL
Non-conforming cases judged by doctors;
like in case of severe anemia, less-volume of blood sampling availability for this study due to severe medical conditions, and so on.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kakeya |
Organization
Osaka City University
Division name
Infection Control Science
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3784
kakeya@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kakeya |
Organization
Osaka City University
Division name
Infection Control Science
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3784
Homepage URL
kakeya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
FUSO Pharmaceutical industries, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 10 | Month | 03 | 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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2014 | Year | 10 | Month | 03 | Day |
Last modified on
| 2014 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017829
