Community-associated Highly-Resistant Enterobacterales

Enterobacteriaceae Infections Clinical Trial

— COCARE  

Official title:

Community-associated Highly-Resistant Enterobacterales

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03924934
• Other study ID #: 18-3017
• Secondary ID: 1R01AI143910
• Status: Enrolling by invitation
• Start date: May 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2020
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carbapenem-Resistant Enterobacteriaceae Infection
• Communicable Diseases
• Community-Acquired Infections
• Cross Infection
• Enterobacteriaceae Infections
• Healthcare Associated Infection
• Infections

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

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