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RecruitingNCT04410276Updated Jun 1, 2020

VENOUS: A Translational Study of Enterococcal Bacteremia

An observational study in Enterococcal Bacteremia, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 12 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-01.

Sponsored by The University of Texas Health Science Center, Houston · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Enterococcal Bacteremia

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Keywords

  • entercoccal bloodstream infection
  • vancomycin-resistant enterococci
  • vancomycin-susceptible enterococci
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized patients

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

Exclusion Criteria:

  • Cultures obtained from patients not admitted to the hospital
  • Isolate(s) not available for further studies.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with enterococcal bloodstream infections

    Adult patients (≥ 18 years of age) with ≥ 1 positive blood cultures with Enterococcus during hospitalization and who have repeat blood culture(s) within 7 days from the first positive culture will be included.

05

What researchers measure

Primary outcomes

  1. All-cause, in-hospital mortality

    Death by any cause while patient is in the hospital

    Time frame: 30 days or until hospital discharge

Secondary outcomes

  1. Number of participants with microbiological outcome

    Eradication defined as a negative follow-up blood culture \> 4 days after index blood culture

    Time frame: 7 days after first documented positive blood culture

  2. Number of participants with recurrence of bacteremia

    Positive blood culture with the same organism within the following 14 days after the documented eradication of bacteremia

    Time frame: 14 days after the documented eradication of bacteremia

06

Study locations

11 of 12 sites recruiting
  • Jackson Health System, University of Miami Miller School of Medicine
    Miami, Florida 33136, United States
    Recruiting
  • Henry Ford Hospital and Medical Centers
    Detroit, Michigan 48202, United States
    Recruiting
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
    Recruiting
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • University of Pittsburgh School of Medicine
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
    Recruiting
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
    Recruiting
  • Hospital Sanatorio
    Buenos Aires, Argentina
    Recruiting
  • Hospital Padre Hurtado
    Santiago, Chile
    Recruiting
  • University of Cologne
    Cologne, Germany
    Not yet recruiting
  • Hospital Universitari de Bellvitge
    Barcelona, Spain
    Recruiting
07

Registry details

Key details

Study ID
NCT04410276
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Cesar A Arias (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jun 1, 2020
Start date
Aug 1, 2016
Primary completion
May 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Jun 1, 2020

Study contacts

Cesar A. Arias, MD, MSc, PhD
Contact
Cesar.Arias@uth.tmc.edu
(713) 500-9000
Truc T. Tran, PharmD
Contact
Truc.T.Tran@uth.tmc.edu
(713) 500-6748
Cesar A. Arias, MD, MSc, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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