Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

PATH

Status: Completed

Conditions: Diarrhea

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00736567

U01AI061187 (U.S. NIH Grant/Contract)

07-0008

Details and patient eligibility

About

PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mortality. The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella species, and Escherichia coli O157:H7. This study will evaluate the performance of the assays and the platform in clinical conditions with non-expert users. It will provide important data on the performance of DEC for at least one target pathogen, an understanding of the potential impact of different sample types on device performance, and human factors associated with instrument interface in the field.

Enrollment: 436 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have 3 or greater liquid stools in the past 24 hours.
• Provide written informed consent from at least one parent in the case of children under 18 years of age.
• Provide written informed consent for those participants above 18 years of age.
• Provide assent in the case of children 10 years of age or greater.

Exclusion criteria

• Previously enrolled in the study.
• Parents are unwilling or unable to provide written informed consent.
• Report using antibiotics in the last 30 days.
• Adolescent (<18 years old) parent of a child already enrolled in the study.