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.
Brief Title
Community-associated Highly-Resistant Enterobacterales
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Enterobacteriaceae Infections
Community-Acquired Infections
Healthcare Associated Infection
Carbapenem-Resistant Enterobacteriaceae Infection
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
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
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
Infection
Bacterial Infection
CRE
Enterobacterales
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT03924934
Org Class
Other
Org Full Name
University of North Carolina, Chapel Hill
Org Study Id
18-3017
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Community-associated Highly-Resistant Enterobacterales
Primary Outcomes
Outcome Description
Proportion of HRE cases diagnosed in hospitalized patients that are community-associated out of all CRE cases in hospitalized patients
Outcome Measure
Proportion of CA-HRE infections
Outcome Time Frame
enrollment - end of study, up to approximately 1 year
Outcome Description
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.
Outcome Measure
Proportion of HRE-culture positive community contacts of hospitalized patients with HRE as determined by stool culture.
Outcome Time Frame
enrollment - end of study, up to approximately 1 year
Secondary Ids
Secondary Id
1R01AI143910
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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)
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)
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Gregory Weston
Investigator Email
gweston@montefiore.org
Investigator Phone
516-859-5255