UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016514 |
|---|---|
| Receipt number | R000019178 |
| Scientific Title | Evaluation study for clinical utility of multiplex molecular test.in treatment for gastrointestinal infectious disease. |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2019/03/12 16:53:43 |
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Basic information
Public title
Evaluation study for clinical utility of multiplex molecular test.in treatment for gastrointestinal infectious disease.
Acronym
GPP Clinical Utility Study
Scientific Title
Evaluation study for clinical utility of multiplex molecular test.in treatment for gastrointestinal infectious disease.
Scientific Title:Acronym
GPP Clinical Utility Study
Region
| Japan |
Condition
Condition
Patients suspected of community-acquired intestinal tract infection treated at Nagasaki University Hospital
Classification by specialty
| Gastroenterology | Infectious disease | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate clinical utility and effectiveness of treatment for gastrointestinal infectious disease of xTAG GPP kit by studying a comparison between prospective test and historical control data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Change in the usage of antimicrobial drug
-Period of administration (prescription) of antimicrobial drug
-Clinical impact rate (only in the prospective observation period)
Key secondary outcomes
-Total dose of the antimicrobial drugs used (by the type of drug, strain, pathogen)
-Cost analysis (cost of medical resource required for diagnosis, treatment and hospitalization)
-Turn-around-time
-Evaluation of testing performance of Luminex xTAG GPP
-Evaluation of the degree of satisfaction of Luminex xTAG GPP in the aspect of medical care
-Evaluation of the frequency of positive result in the items other than those requested f or usual examination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Overview of the prospective observation period (period using the xTAG GPP kit) The xTAG GPP kit test shall be performed in addition to usual care for medical examination.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with the symptoms of diarrhea and possible to undergo the test using feces
2.Patients aged 16 years or older
Key exclusion criteria
1.Patients considered inappropriate by the physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Yanagihara |
Organization
Nagasaki University Hospital
Division name
Department of Laboratory Medicine
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7574
k-yanagi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Kosai |
Organization
Nagasaki University Hospital
Division name
Department of Laboratory Medicine
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7574
Homepage URL
k-kosai@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Luminex Japan Corporation 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
| 2015 | Year | 02 | Month | 16 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019178
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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