NCT04410276

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
5 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

8.8 years

First QC Date

May 26, 2020

Last Update Submit

May 26, 2020

Conditions

Enterococcal Bacteremia

Keywords

entercoccal bloodstream infectionvancomycin-resistant enterococcivancomycin-susceptible enterococci

Outcome Measures

Primary Outcomes (1)

  • All-cause, in-hospital mortality

    Death by any cause while patient is in the hospital

    30 days or until hospital discharge

Secondary Outcomes (2)

  • Number of participants with microbiological outcome

    7 days after first documented positive blood culture

  • Number of participants with recurrence of bacteremia

    14 days after the documented eradication of bacteremia

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients

You may qualify if:

  • 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

You may not qualify if:

  • Cultures obtained from patients not admitted to the hospital
  • Isolate(s) not available for further studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Jackson Health System, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

RECRUITING

Henry Ford Hospital and Medical Centers

Detroit, Michigan, 48202, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

RECRUITING

Hospital Sanatorio

Buenos Aires, Argentina

RECRUITING

Hospital Padre Hurtado

Santiago, Chile

RECRUITING

University of Cologne

Cologne, Germany

NOT YET RECRUITING

Hospital Universitari de Bellvitge

Barcelona, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Enterococcal isolates from index and subsequent blood cultures will be collected by the research personnel from the clinical microbiology lab. Bacterial isolates will be processed by conventional laboratory methods at each institution. Isolates will be stored at -80º Celsius using local laboratory standards until shipment to central laboratory (UTHealth) for storage and further characterization.

Study Officials

  • Cesar A. Arias, MD, MSc, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar A. Arias, MD, MSc, PhD

CONTACT

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

Truc T. Tran, PharmD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 1, 2020

Study Start

August 1, 2016

Primary Completion

May 31, 2025

Study Completion

August 31, 2025

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations

CL(1)AR(1)DE(1)ES(1)US(8)