Trials / Completed

CompletedNCT03924934

Community-associated Highly-Resistant Enterobacterales

Status: Completed
Phase: —
Study type: Observational
Enrollment: 2,172 (actual)

Sponsor: University of North Carolina, Chapel Hill · Academic / Other
Sex: All
Age: 18 Years – 99 Years
Healthy volunteers: Not accepted

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

Timeline

Start date: 2019-05-01
Primary completion: 2024-12-01
Completion: 2024-12-01
First posted: 2019-04-23
Last updated: 2025-05-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03924934. Inclusion in this directory is not an endorsement.