VENOUS: A Translational Study of Enterococcal Bacteremia

Enterococcal Bacteremia Clinical Trial

Official title:

VENOUS: A Translational Study of Enterococcal Bacteremia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04410276
• Other study ID #: HSC-MS-15-0055
• Status: Recruiting
• Start date: August 1, 2016
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: Cesar A. Arias, MD, MSc, PhD
• Phone: (713) 500-9000
• Email: Cesar.Arias[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Enterococcal Bacteremia

Locations

Country	Name	City	State
Argentina	Hospital Sanatorio	Buenos Aires
Chile	Hospital Padre Hurtado	Santiago
Germany	University of Cologne	Cologne
Spain	Hospital Universitari de Bellvitge	Barcelona
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Henry Ford Hospital and Medical Centers	Detroit	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Jackson Health System, University of Miami Miller School of Medicine	Miami	Florida
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause, in-hospital mortality	Death by any cause while patient is in the hospital	30 days or until hospital discharge
Secondary	Number of participants with microbiological outcome	Eradication defined as a negative follow-up blood culture > 4 days after index blood culture	7 days after first documented positive blood culture
Secondary	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	14 days after the documented eradication of bacteremia