DiarrheaNCT03394040
Point-of-Use Pathogen Identification Tool for Diarrhea
An observational study of Diarrhea, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diarrhea
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 23 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study seeks individuals of all ages experiencing diarrhea from the Washington Metropolitan area
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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
Read the detailed description
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.
- Conditions
- Diarrhea
- Keywords
- Diarrhea, Point-of-Need, Pathogen Identification
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The study seeks individuals of all ages experiencing diarrhea from the Washington Metropolitan area |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start14 Feb 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Why it stopped: PI left the NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Wendy A Henderson, C.R.N.P., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394040
- Sponsor's protocol ID
- 180040
- Other IDs
- 18-NR-0040
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Use Pathogen Identification Tool for Diarrhea
- ClinicalTrials.gov ID
- NCT03394040
- Acronym / sponsor ID
- 180040
- Conditions
- Diarrhea
- Keywords
- Diarrhea, Point-of-Need, Pathogen Identification
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the NIH
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The study seeks individuals of all ages experiencing diarrhea from the Washington Metropolitan area |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study seeks individuals of all ages experiencing diarrhea from the Washington Metropolitan area
Key inclusion criteria (6 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: At enrollment
The study aims to validate the tool in detecting pathogens that cause diarrhea.
Results and safety
The study was stopped early (reason given: PI left the NIH). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy A Henderson, C.R.N.P. principal investigator
National Institute of Nursing Research (NINR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the NIH). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.