Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 1:27 AM
Study NCT ID:
NCT03924934
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2019-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-associated Highly-Resistant Enterobacterales
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of CA-HRE infections', 'timeFrame': 'enrollment - end of study, up to approximately 1 year', 'description': 'Proportion of HRE cases diagnosed in hospitalized patients that are community-associated out of all CRE cases in hospitalized patients'}, {'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', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infection', 'Bacterial Infection', 'CRE', 'Enterobacterales'], 'conditions': ['Enterobacteriaceae Infections', 'Community-Acquired Infections', 'Healthcare Associated Infection', 'Carbapenem-Resistant Enterobacteriaceae Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Four categories of participants will be included:\n\n1. 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)\n2. Hospitalized patients with healthcare-associated HRE, who are not discharged home (HA-HRE) (210 selected control patients)\n3. 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)\n4. Contacts of patients with HRE (approximately 1,500)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCategory 1: Patients who live at home and meet the following criteria:\n\n* CDC-defined HRE isolated during a previous hospitalization or outpatient visit\n* Home origin\n* First positive HRE culture within 48 hours of admission (in case of hospitalization)\n\nCategory 2: Hospitalized patients with CDC-defined HRE isolated during hospitalization who are not discharged home and who meet any of the following criteria:\n\n* Admitted from other care facility (not home origin)\n* Do not have first positive HRE culture within 48 hours of admission\n\nCategory 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:\n\n* Admitted from other care facility (not home origin)\n* Do not have first positive HRE culture within 48 hours of admission (in case of hospitalization)\n\nCategory 4: Participants who meet the following criteria:\n\n• Community contact of a participant in Category 1 and/or 3.\n\nExclusion Criteria:\n\nIn all categories, participants who meet the following criteria will be excluded:\n\n• Age \\<18 years\n\nIn category 1, the following are exclusionary:\n\n* pre-existing renal failure\n* pre-existing liver disease\n* immunocompromised\n* history of malignancy\n* pregnancy\n\nIn addition, in category 1, 3 and 4, who meet the following criteria will be excluded:\n\n• Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03924934', 'acronym': 'COCARE', 'briefTitle': 'Community-associated Highly-Resistant Enterobacterales', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Community-associated Highly-Resistant Enterobacterales', 'orgStudyIdInfo': {'id': '18-3017'}, 'secondaryIdInfos': [{'id': '1R01AI143910', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI143910', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Possible CA-HRE', 'description': '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)'}, {'label': 'HA-HRE', 'description': 'Hospitalized patients with healthcare-associated HRE, who are not discharged home (HA-HRE) (210 selected control patients)'}, {'label': 'HA-HRE discharged home', 'description': 'Patients eventually discharged home, either directly or through another facility, after a hospitalization during which HA-HRE was isolated from a clinical culture (100)'}, {'label': 'Community contacts', 'description': 'Contacts of patients with HRE (approximately 1,500)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'David van Duin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'timeFrame': '9-36 months following publication', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'IRB approval, DUA executed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}