VENOUS: A Translational Study of Enterococcal Bacteremia

Recruiting

• Conditions: Enterococcal Bacteremia

• Registration Number: NCT04410276
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Last Update Submitted: 2020-05-26
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Jackson Health System, University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Henry Ford Hospital and Medical Centers; 🇺🇸 Detroit, Michigan, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pittsburgh School of Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Hospital Sanatorio; 🇦🇷 Buenos Aires, Argentina

Hospital Padre Hurtado; 🇨🇱 Santiago, Chile

Scroll for more (2 remaining)