Community-associated Carbapenem-Resistant Enterobacteriaceae

Community-associated Carbapenem-Resistant Enterobacteriaceae

Sponsors

Lead sponsor: University of North Carolina, Chapel Hill

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Source University of North Carolina, Chapel Hill
Brief Summary

This is a prospective multi-center study. Bacterial isolates from hospitalized patients with CA-CRE will be compared to those from hospitalized patients with healthcare-associated CRE (HA-CRE). In addition, community spread of CRE will be determined.

Detailed Description

Patients who are discharged home from the hospital and meet criteria for possible CA-CRE 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 CRE intestinal carriage. Contacts of the index participant will also be approached and mailed a BioWipe kit to screen for the presence of CRE 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 CRE isolated during hospitalization who are not discharged home will also be included. All CRE 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.

Overall Status Enrolling by invitation
Start Date May 1, 2019
Completion Date December 2024
Primary Completion Date December 2024
Study Type Observational
Primary Outcome
Measure Time Frame
Proportion of CA-CRE infections enrollment - end of study, up to approximately 1 year
Proportion of CRE-culture positive community contacts of hospitalized patients with CRE as determined by stool culture. enrollment - end of study, up to approximately 1 year
Enrollment 2020
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

Category 1: Patients who live at home and meet the following criteria:

- CDC-defined CRE isolated during hospitalization or outpatient visit

- Home origin

- First positive CRE culture within 48 hours of admission (in case of hospitalization)

Category 2: Hospitalized patients with CDC-defined CRE 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 CRE culture within 48 hours of admission

Category 3: Patients with CDC-defined CRE isolated during hospitalization or outpatient visit who are discharged home and who meet any of the following criteria:

- Admitted from other care facility (not home origin)

- Do not have first positive CRE 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

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David van Duin, MD, PhD Principal Investigator University of North Carolina, Chapel Hill
Location
facility University of North Carolina at Chapel Hill
Location Countries

United States

Verification Date

December 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Possible CA-CRE

Description: Hospitalized patients with suspected CA-CRE, who are discharged home (approximately 210 patients)

Arm group label: HA-CRE

Description: Hospitalized patients with healthcare-associated CRE, who are not discharged home (HA-CRE) (210 selected control patients)

Arm group label: HA-CRE discharged home

Description: Patients discharged home after a hospitalization during which HA-CRE was isolated from a clinical culture (100)

Arm group label: Community contacts

Description: Contacts of patients with CRE (approximately 1,500)

Acronym COCARE
Patient Data Yes
Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov