Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04410276

Conditions

Enterococcal Bacteremia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Enterococcal Bacteremia

Study ID

NCT04410276

Start date

Aug 1, 2016

Status verified date

May, 2020

Completion date

Aug 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • All-cause, in-hospital mortality [ Time Frame: 30 days or until hospital discharge ]

Central Contacts and Locations

Central contacts

Cesar A. Arias, MD, MSc, PhD

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

Truc T. Tran, PharmD

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

Locations

Jackson Health System, University of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Lilian Abbo, MD

labbo@med.miami.edu

Henry Ford Hospital and Medical Centers

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Katherine Reyes, MD, PhD

Kreyes1@hfhs.org

Marcus Zeryos, MD

mzervos@hfhs.org

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Luis Shimose, MD

lshimoseciudad@umc.edu

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

David van Duin, MD, PhD

David_vanduin@med.unc.edu

University of Pittsburgh School of Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Yohei Doi, MD, PhD

yod4@pitt.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Samuel Shelburne, MD, PhD

sshelburne@mdanderson.org

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Cesar A. Arias, MD, MSc, PhD

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

Truc T. Tran, PhD

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

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Catherine Liu, MD

Catherine.liu@fredhutch.org

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 1, 2020

Last verified

May, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2020-06-01.