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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name