Clinical trial NCT04410276: VENOUS: A Translational Study of Enterococcal Bacteremia
Official title: VENOUS: A Translational Study of Enterococcal Bacteremia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Enterococcal Bacteremia
Keywords: entercoccal bloodstream infection
vancomycin-resistant enterococci
vancomycin-susceptible enterococci
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief summary: The purpose of this study is to assemble a multicenter prospective cohort of patients with enterococcal bloodstream infections (BSIs) to provide data on outcomes of patients with enterococcal BSIs for sample size calculations for future trials, as well as to characterize enterococcal isolates causing BSIs in order to comprehensively dissect the molecular epidemiology of infecting organisms for future studies.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patient
* ≥1 positive blood culture with Enterococcus spp. (VRE or VSE) during hospitalization
* bacterial isolate(s) is/are available for further characterization
* Repeat blood culture(s) within 7 days from the first positive culture

Exclusion Criteria:

* Cultures obtained from patients not admitted to the hospital
* Isolate(s) not available for further studies.

Primary outcomes:
measure: All-cause, in-hospital mortality
timeFrame: 30 days or until hospital discharge
Secondary outcomes:
measure: Number of participants with microbiological outcome
timeFrame: 7 days after first documented positive blood culture
measure: Number of participants with recurrence of bacteremia
timeFrame: 14 days after the documented eradication of bacteremia
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Health System, University of Miami Miller School of Medicine
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital and Medical Centers
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Sanatorio
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
city: Cologne
country: Germany
facility: University of Cologne
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Cesar A. Arias, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: