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VENOUS: A Translational Study of Enterococcal Bacteremia

NCT ID: NCT04410276

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Enterococcal Bacteremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Cesar A Arias

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cesar A. Arias, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Jackson Health System, University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status RECRUITING

Henry Ford Hospital and Medical Centers

Detroit, Michigan, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status RECRUITING

Hospital Sanatorio

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital Padre Hurtado

Santiago, , Chile

Site Status RECRUITING

University of Cologne

Cologne, , Germany

Site Status NOT_YET_RECRUITING

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status RECRUITING

Countries

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United States Argentina Chile Germany Spain

Central Contacts

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Cesar A. Arias, MD, MSc, PhD

Role: CONTACT

[email protected]
(713) 500-9000

Truc T. Tran, PharmD

Role: CONTACT

[email protected]
(713) 500-6748

Facility Contacts

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Lilian Abbo, MD

Role: primary

[email protected]

Katherine Reyes, MD, PhD

Role: primary

[email protected]

Marcus Zeryos, MD

Role: backup

[email protected]

Luis Shimose, MD

Role: primary

[email protected]

David van Duin, MD, PhD

Role: primary

[email protected]

Yohei Doi, MD, PhD

Role: primary

[email protected]

Samuel Shelburne, MD, PhD

Role: primary

[email protected]

Cesar A. Arias, MD, MSc, PhD

Role: primary

[email protected]
713-500-9000

Truc T. Tran, PhD

Role: backup

[email protected]
(713) 500-6748

Catherine Liu, MD

Role: primary

[email protected]

Fernanda Barberis, MD

Role: primary

[email protected]

José M. Munita, MD

Role: primary

[email protected]

Harald Seifert, MD

Role: primary

[email protected]

Carlota Guidiol, MD

Role: primary

[email protected]

Other Identifiers

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HSC-MS-15-0055

Identifier Type: -

Identifier Source: org_study_id

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