Community-associated Highly-Resistant Enterobacterales (COCARE)

University of North Carolina (UNC)

Status: Completed

Conditions: Healthcare Associated Infection; Enterobacteriaceae Infections; Carbapenem-Resistant Enterobacteriaceae Infection; Community-Acquired Infections

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03924934

18-3017

1R01AI143910 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,172 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,172 participants in 4 patient groups

Possible CA-HRE

Description:

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)

HA-HRE

Description:

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

HA-HRE discharged home

Description:

Patients eventually discharged home, either directly or through another facility, after a hospitalization during which HA-HRE was isolated from a clinical culture (100)

Community contacts

Description:

Contacts of patients with HRE (approximately 1,500)