UMIN-CTR Clinical Trial

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
Last 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
Email	k-yanagi@nagasaki-u.ac.jp

Public contact
1st 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
Email	k-kosai@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019178