VENOUS: A Translational Study of Enterococcal Bacteremia

May 26, 2020 updated by: Cesar A Arias, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
  • Chile
  • Germany
  • Spain
      • Barcelona, Spain
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Jackson Health System, University of Miami Miller School of Medicine
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital and Medical Centers
        • Contact:
        • Contact:
    • Mississippi
      • Jackson, Mississippi, United States, 39216
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh School of Medicine
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Contact:
      • Houston, Texas, United States, 77030
    • Washington
      • Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with microbiological outcome
Time Frame: 7 days after first documented positive blood culture
Eradication defined as a negative follow-up blood culture > 4 days after index blood culture
7 days after first documented positive blood culture
Number of participants with recurrence of bacteremia
Time Frame: 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
14 days after the documented eradication of bacteremia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Cesar A. Arias, MD, MSc, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

May 31, 2025

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-15-0055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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