Trials Sponsors Conditions Drugs Pricing

Conditions

Enterobacteriaceae Infections Community-Acquired Infections Healthcare Associated Infection Carbapenem-Resistant Enterobacteriaceae Infection

Keywords

InfectionBacterial InfectionCREEnterobacterales

Outcome Measures

Primary Outcomes (2)

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

Study Arms (4)

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)

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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)

You may qualify if:

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHcollaborator
University of North Carolina, Chapel Hill
Otherlead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

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

MeSH Terms

Conditions

Enterobacteriaceae InfectionsCommunity-Acquired InfectionsCross InfectionInfectionsBacterial Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial Infections and MycosesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

David van Duin, MD, PhD
University of North Carolina, Chapel Hill
PRINCIPAL INVESTIGATOR

Enrollment

2,172 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 23, 2019

Study Start

May 1, 2019

Actual (reported)

Community-associated Highly-Resistant Enterobacterales

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Possible CA-HRE

HA-HRE

HA-HRE discharged home

Community contacts

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Possible CA-HRE

HA-HRE

HA-HRE discharged home

Community contacts

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations