Evaluation study for clinical utility of multiplex molecular test.in treatment for gastrointestinal infectious disease.

Evaluation study for clinical utility of multiplex molecular test.in treatment for gastrointestinal infectious disease. - GPP Clinical Utility Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016514

Enrollment

100

Registered

2015-02-16

Start date

2015-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suspected of community-acquired intestinal tract infection treated at Nagasaki University Hospital

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with the symptoms of diarrhea and possible to undergo the test using feces 2.Patients aged 16 years or older

Exclusion criteria

Exclusion criteria: 1.Patients considered inappropriate by the physician in charge

Design outcomes

Primary

Measure	Time frame
-Change in the usage of antimicrobial drug -Period of administration (prescription) of antimicrobial drug -Clinical impact rate (only in the prospective observation period)	—

Secondary

Measure	Time frame
-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	—

Measure

Time frame

-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

—

Countries

Japan

Contacts

Public ContactKosuke Kosai

Nagasaki University Hospital Department of Laboratory Medicine

k-kosai@nagasaki-u.ac.jp095-819-7574

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026