Community-associated Highly-Resistant Enterobacterales

NCT ID: NCT03924934

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2024-12-01

Brief Summary

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.

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

HA-HRE

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

No interventions assigned to this group

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)

No interventions assigned to this group

Community contacts

Contacts of patients with HRE (approximately 1,500)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David van Duin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

1R01AI143910

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-3017

Identifier Type: -

Identifier Source: org_study_id