Point-of-Use Pathogen Identification Tool for Diarrhea

NCT03394040 | Terminated

• 2 other identifiers: 18004018-NR-0040
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhea

Keywords

Diarrhea; Point-of-Need; Pathogen Identification

Outcome Measures

Primary Outcomes (1)

• 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.

  The study aims to validate the tool in detecting pathogens that cause diarrhea.

  At enrollment

Study Arms (1)

1

The study seeks individuals of all ages experiencing diarrhea from the Washington Metropolitan area

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study seeks individuals of all ages experiencing diarrhea from the Washington Metropolitan area

You may qualify if:

• 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.

You may not qualify if:

• This protocol will exclude outpatients who are clinically unstable patients. Clinically unstable patient is defined as someone requiring emergent care or hospitalization.
• NINR employees, subordinates/relatives/ or co-workers.
• Any NIH employee who is a subordinates/relatives/or co-workers of study investigator.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy A Henderson, C.R.N.P.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 9, 2018
• Study Start: February 14, 2019
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

US (1)