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 what germs cause diarrhea. It is a simple paper strip test and doesn t require electric power. This may make it easier for health care workers to more quickly fight diarrheal diseases.
Objective:
To test a tool that may detect what germs cause diarrhea.
Eligibility:
People already enrolled in an active NIH protocol who have diarrhea
Design:
Participants will have 1 or 2 studies. They will give information about their symptoms, current medicines, and basic personal data. They will give a stool sample.
Part of each sample will be tested in a lab. The rest will be stored indefinitely. No personal data will be connected to the samples. The stored samples may be used in future research.
Positive test results will be reported to a participant s primary doctor
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Institutes of Health Clinical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
INCLUSION CRITERIA:
We will include samples from participants with self-reported or clinical provider documented diarrhea defined as one or more loose or watery stools per day as defined by criteria a or b below:
- Cases of acute diarrhea (i.e., diarrhea which is currently active or was experienced up to one day prior to sampling or still active during sampling) will be included.
- Cases of persistent diarrhea (i.e., diarrhea which is chronic or chronic-intermittently, i.e., once a week or more, experienced for at least 2 to 4 weeks prior to sampling), will be included. In the case of chronic diarrhea, diarrhea does not have to be active on the day of, or immediately prior to (i.e., one day) sampling.
- Current enrollment in an active NIH protocol or enrollment in 12-NR-0195.
- Able to provide 50ml stool sample within 2-3 hours.
- Children will only be enrolled if they are currently enrolled in an active NIH protocol or enrolled in 12-NR-0195.
EXCLUSION CRITERIA:
- This protocol will exclude outpatients who are clinically unstable patients. Clinically unstable patient is defined as someone requiring emergent care or hospitalization.
- Antibiotic use, which can affect intestinal flora, is not exclusionary but will be controlled for via post-hoc analysis.
- NINR employees, subordinates/relatives/ or co-workers.
- Any NIH employee who is a subordinates/relatives/or co-workers of study investigator.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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1
The study seeks individuals of all ages experiencing diarrhea from the Washington Metropolitan area
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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The primary objective of this study is to validate the tool in detecting diarrhea causing pathogens in stool. The sensitivity and specificity of the tool to identify the common diarrhea causing pathogens in the US.
Délai: At enrollment
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The study aims to validate the tool in detecting pathogens that cause diarrhea.
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At enrollment
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Wendy A Henderson, C.R.N.P., National Institute of Nursing Research (NINR)
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 180040
- 18-NR-0040
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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