Community-associated Highly-Resistant Enterobacterales

NCT03924934 | Completed

• 2 other identifiers: 18-30171R01AI143910
• Study Type: observational
• Target: 2,172
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Infection; Bacterial Infection; CRE; Enterobacterales

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

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)

HA-HRE

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

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)

Community contacts

Contacts of patients with HRE (approximately 1,500)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Four categories of participants will be included: 1. 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) 2. Hospitalized patients with healthcare-associated HRE, who are not discharged home (HA-HRE) (210 selected control patients) 3. Patients eventually discharged home either directly or through another facility after a hospitalization or outpatient visit during which HA-HRE was isolated from a clinical culture (100) 4. Contacts of patients with HRE (approximately 1,500)

You may qualify if:

• 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.

You may not qualify if:

• In all categories, participants who meet the following criteria will be excluded:
• Age \<18 years
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

HRE that are recovered either from clinical samples or from Biowipe samples will be sent to a central research laboratory for species confirmation and antibacterial susceptibility testing

MeSH Terms

Conditions

Enterobacteriaceae Infections; Community-Acquired Infections; Cross Infection; Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David van Duin, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 23, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9-36 months following publication
• Access Criteria: IRB approval, DUA executed

Locations

US (1)