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Point-of-Use Pathogen Identification Tool for Diarrhea | Clinical Trials | Clareo Health

TERMINATEDNCT03394040

Point-of-Use Pathogen Identification Tool for Diarrhea

Background: Many people suffer from diarrhea every year. In the United States, it leads to about 130,000 hospitalizations and 3,000 deaths a year. Researchers want to test a tool that may show them w...

Lead sponsor: National Institute of Nursing Research (NINR)•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

National Institute of Nursing Research (NINR)

Objective This is a cross-sectional study to validate a new, simple, rapid and affordable point-of-use pathogen identification research tool (hence forth referred to as the "tool") of diarrheal diseases for potential use in resource limited settings in the future. The tool was developed under the terms of a National Institutes of Health (NIH) approved Clinical CRADA between NINR and GoDx, Inc. The sensitivity and specificity of the tool in identifying several common gastrointestinal (GI) pathogens in stool will be examined in participants with diarrhea. The proposed validation study will constitute the initial assessment of the tool in a healthcare environment. Once the detection validity and technical performance of the tool have been evaluated in this context, the tool will be further tested in low resource healthcare settings. Study population Study participants will be recruited from the Washington, DC, metropolitan area using standard NIH recruitment practices, as well as from among participants in two existing protocols (09-NR-0064, 12-NR-0195) which recruit and consent research participants with GI disorders and diseases. Lastly, participants enrolled on other NIH protocols will be recruited. Appropriate stool samples may also be sequestered from an exempt repository protocol (09-NR-N228). All ages, ethnicities and both sexes will be considered for inclusion in this study. The study population would reflect the demographics of the greater Washington DC metropolitan area. Externally recruited participants and participants recruited from existing protocols will be asked to supply stool samples. A total of 800 samples from participants with diarrhea will be included in this study. Design Stool samples will be collected from participants with diarrhea for which pathogen testing using the NIH standard of care, BioFire FilmArray GI Pathogen Panel (FDA approved PCR based pathogen diagnostic) by the Department of Laboratory Medicine (DLM) is indicated. Collected stool samples will be tested for pathogens causing GI disease, using the FilmArray GI panel by the DLM. Technicians in the NINR laboratories will test aliquots from the same stool samples using our tool. The tool has been designed for detection of the most common diarrhea causing pathogens. Of primary interest for this study are: Enteropathogenic Escherichia coli - EPEC, Clostridium difficile C. difficile, Enteroaggregative Escherichia coli - EAEC, and Campylobacter spp. Pathogens of secondary interests, but for which the study is not specifically powered, will also be included and are: Shigella sp., Shiga Toxin-Producing Escherichia coli - STEC, Salmonella spp., and Cryptosporidium spp. Participants will not receive results from the tool. Outcome measures The percent sensitivity (ability to make the correct positive identification), specificity (ability to make the correct negative identification) and 95% confidence intervals will be statistically determined by comparing the results yielded by the tool and the FilmArray GI panel. Controlled laboratory experiments suggest \>90% specificity and sensitivity of the tool for the detection of the specified pathogens.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 6, 2020Terms

Trial snapshot

StatusTERMINATED

Phase—

Enrollment1,000

Start dateFeb 2019

Last updatedJan 6, 2020

Condition

Diarrhea

Locations shown

National Institutes of Health Clinical Center

Bethesda, Maryland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2020Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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