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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI143910 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Category 1: Patients who live at home and meet the following criteria:
Category 2: Hospitalized patients with CDC-defined HRE isolated during hospitalization who are not discharged home and who meet any of the following criteria:
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:
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:
In addition, in category 1, 3 and 4, who meet the following criteria will be excluded:
• Unable to provide informed consent
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Four categories of participants will be included:
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| Name | Affiliation | Role |
|---|---|---|
| David van Duin, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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9-36 months following publication
IRB approval, DUA executed
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| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D017714 | Community-Acquired Infections |
| D003428 | Cross Infection |
| D007239 | Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
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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
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |