VENOUS: A Translational Study of Enterococcal Bacteremia

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04410276

Enrollment

1000

Registered

2020-06-01

Start date

2016-08-01

Completion date

2025-08-31

Last updated

2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterococcal Bacteremia

Keywords

entercoccal bloodstream infection, vancomycin-resistant enterococci, vancomycin-susceptible enterococci

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
All-cause, in-hospital mortality	30 days or until hospital discharge	Death by any cause while patient is in the hospital

Secondary

Measure	Time frame	Description
Number of participants with microbiological outcome	7 days after first documented positive blood culture	Eradication defined as a negative follow-up blood culture \> 4 days after index blood culture
Number of participants with recurrence of bacteremia	14 days after the documented eradication of bacteremia	Positive blood culture with the same organism within the following 14 days after the documented eradication of bacteremia

Countries

Argentina, Chile, Germany, Spain, United States

Contacts

Primary ContactCesar A. Arias, MD, MSc, PhD

Cesar.Arias@uth.tmc.edu(713) 500-9000

Backup ContactTruc T. Tran, PharmD

Truc.T.Tran@uth.tmc.edu(713) 500-6748

Outcome results