Community-associated Highly-Resistant Enterobacterales

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

• Registration Number: NCT03924934
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Study Start: 2019-05-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2020

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of HRE-culture positive community contacts of hospitalized patients with HRE as determined by stool culture.	enrollment - end of study, up to approximately 1 year	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.
Proportion of CA-HRE infections	enrollment - end of study, up to approximately 1 year	Proportion of HRE cases diagnosed in hospitalized patients that are community-associated out of all CRE cases in hospitalized patients

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States