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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Community-associated Highly-Resistant Enterobacterales

Clinicaltrials.gov identifier NCT03924934

Recruitment Status Enrolling by invitation

First Posted April 23, 2019

Last update posted March 24, 2021

Study Description

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.

  • Condition or Disease:Community-Acquired Infections
    Healthcare Associated Infection
    Carbapenem-Resistant Enterobacteriaceae Infection
    Enterobacteriaceae Infections
  • Intervention/Treatment:
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 2020 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: Community-associated Highly-Resistant Enterobacterales
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2024
  • Estimated Study Completion Date: December 2024
Outcome Measures
  • Primary Outcome Measures: 1. Proportion of CA-HRE infections [ Time Frame: enrollment - end of study, up to approximately 1 year ]
    Proportion of HRE cases diagnosed in hospitalized patients that are community-associated out of all CRE cases in hospitalized patients
  • 2. Proportion of HRE-culture positive community contacts of hospitalized patients with HRE as determined by stool culture. [ Time Frame: enrollment - end of study, up to approximately 1 year ]
    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.
  • 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

Eligibility Criteria
  • Ages Eligible for Study: 18 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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)
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

Contacts and Locations
Contacts
Locations

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator: David van Duin, MD, PhD University of North Carolina, Chapel Hill

More Information
  • Responsible Party: University of North Carolina, Chapel Hill
  • ClinicalTrials.gov Identifier: NCT03924934 History of Changes
  • Other Study ID Numbers: 18-3017, 1R01AI143910
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: March 24, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan 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.
  • Time Frame: 9-36 months following publication
  • Access Criteria: IRB approval, DUA executed
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of North Carolina, Chapel Hill: Bacterial Infection
    Enterobacterales
    Infection
    CRE
  • Additional relevant MeSH terms: Infection
    Cross Infection
    Communicable Diseases
    Enterobacteriaceae Infections
    Community-Acquired Infections