- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924934
Community-associated Highly-Resistant Enterobacterales (COCARE)
Study Overview
Status
Detailed Description
Patients who are discharged home from the hospital and meet criteria for possible CA-HRE will be recruited. These index participants will be interviewed to determine the epidemiologic network, and will be mailed a monthly BioWipe kit to screen for ongoing HRE intestinal carriage. Contacts of the index participant will also be approached and mailed a BioWipe kit to screen for the presence of HRE and/or carbapenemase gene(s) that were present in the index patient. If this initial sample is negative, the contact is not further interviewed or tested. If the initial screening is positive for the carbapenemase gene of interest, then the contact will be asked to answer the same questions as the index patient and will receive a monthly BioWipe kit. For each positive contact, a second-generation network of contacts will be constructed, who in turn will be approached for screening.
An additional subset of participants, those with CDC-defined HRE isolated during hospitalization who are not discharged home will also be included. All HRE isolates that are isolated from the patient as part of routine clinical care will be sub-cultured and shipped to the central research laboratory. A limited data set will be collected.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Four categories of participants will be included:
- Patients with suspected CA-HRE, discharged home after a previous hospitalization or outpatient visit during which CA-HRE was isolated from a clinical culture (approximately 210 patients)
- Hospitalized patients with healthcare-associated HRE, who are not discharged home (HA-HRE) (210 selected control patients)
- Patients eventually discharged home either directly or through another facility after a hospitalization or outpatient visit during which HA-HRE was isolated from a clinical culture (100)
- Contacts of patients with HRE (approximately 1,500)
Description
Inclusion Criteria:
Category 1: Patients who live at home and meet the following criteria:
- CDC-defined HRE isolated during a previous hospitalization or outpatient visit
- Home origin
- First positive HRE culture within 48 hours of admission (in case of hospitalization)
Category 2: Hospitalized patients with CDC-defined HRE isolated during hospitalization who are not discharged home and who meet any of the following criteria:
- Admitted from other care facility (not home origin)
- Do not have first positive HRE culture within 48 hours of admission
Category 3: Patients with CDC-defined HRE isolated during a previous hospitalization or outpatient visit who are eventually discharged home and who meet any of the following criteria:
- Admitted from other care facility (not home origin)
- Do not have first positive HRE culture within 48 hours of admission (in case of hospitalization)
Category 4: Participants who meet the following criteria:
• Community contact of a participant in Category 1 and/or 3.
Exclusion Criteria:
In all categories, participants who meet the following criteria will be excluded:
• Age <18 years
In category 1, the following are exclusionary:
- pre-existing renal failure
- pre-existing liver disease
- immunocompromised
- history of malignancy
- pregnancy
In addition, in category 1, 3 and 4, who meet the following criteria will be excluded:
• Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Possible CA-HRE
Patients with suspected CA-HRE, discharged home after a previous hospitalization or outpatient visit during which CA-HRE was isolated from a clinical culture (approximately 210 patients)
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HA-HRE
Hospitalized patients with healthcare-associated HRE, who are not discharged home (HA-HRE) (210 selected control patients)
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HA-HRE discharged home
Patients eventually discharged home, either directly or through another facility, after a hospitalization during which HA-HRE was isolated from a clinical culture (100)
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Community contacts
Contacts of patients with HRE (approximately 1,500)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of CA-HRE infections
Time Frame: enrollment - end of study, up to approximately 1 year
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Proportion of HRE cases diagnosed in hospitalized patients that are community-associated out of all CRE cases in hospitalized patients
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enrollment - end of study, up to approximately 1 year
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Proportion of HRE-culture positive community contacts of hospitalized patients with HRE as determined by stool culture.
Time Frame: enrollment - end of study, up to approximately 1 year
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In community contacts of patients discharged from the hospital after HRE diagnosis, the presence or absence of HRE in stool samples will be determined by culture.
Then, the total number of community contacts with HRE-positive stool cultures will be divided by the total number of tested community contacts to derive the proportion of community contacts with stool cultures positive for HRE.
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enrollment - end of study, up to approximately 1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: David van Duin, MD, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-3017
- 1R01AI143910 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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