VENOUS: A Translational Study of Enterococcal Bacteremia | NCT04410276

Studies
VENOUS: A Translational Study of Enterococcal Bacteremia

NCT04410276

Sponsor

The University of Texas Health Science Center, Houston

Status

Unknown status

Last Update Posted

Jun 1, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Enterococcal Bacteremia

Interventions

Not provided

Countries

United States
Argentina
Chile
Germany
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

May 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 26, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2020

Last Update Posted Date

Jun 1, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cesar A Arias, Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with microbiological outcome	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospitalized patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cesar A. Arias, MD, MSc, PhD	Contact	(713) 500-9000		Cesar.Arias@uth.tmc.edu
Truc T. Tran, PharmD	Contact	(713) 500-6748		Truc.T.Tran@uth.tmc.edu

Overall Officials

Name	Affiliation	Role
Cesar A. Arias, MD, MSc, PhD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jackson Health System, University of Miami Miller School of Medicine	Recruiting	Miami	Florida	33136	United States

Description

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.