Clinical trial NCT03924934: Community-associated Highly-Resistant Enterobacterales
Official title: Community-associated Highly-Resistant Enterobacterales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterobacteriaceae Infections
Community-Acquired Infections
Healthcare Associated Infection
Carbapenem-Resistant Enterobacteriaceae Infection
Keywords: Infection
Bacterial Infection
CRE
Enterobacterales
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-04-23
Enrollment: 2172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

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.

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

Primary outcomes:
measure: Proportion of CA-HRE infections
timeFrame: enrollment - end of study, up to approximately 1 year
measure: Proportion of HRE-culture positive community contacts of hospitalized patients with HRE as determined by stool culture.
timeFrame: enrollment - end of study, up to approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: David van Duin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: