ClinicalTrials.gg
RecruitingNCT04410276Updated Jun 1, 2020

VENOUS: A Translational Study of Enterococcal Bacteremia

An observational study in Enterococcal Bacteremia, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 12 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-01.

Sponsored by The University of Texas Health Science Center, Houston · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Aug 2016; still recruiting 10 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 79 studies in Bacteremia with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Bacteremia · United States.

Planned enrollment
10th of 32
1,000 · median 470
Started
2016
with 2 others
Observational
32 of 79
2 open now
Registered
68th of 79
by date

Among the 79 studies in Bacteremia with a site in United States, this one is the 10th largest by planned enrollment of the 32 observational ones, is one of 3 that started in 2016, is one of 32 observational ones, and was the 68th registered.

By phase

79 studies; the count open now beside each. This study's row is marked.

Observationalthis study32 · 2 open
No phase11 · 1 open
Phase 211 · 1 open
Phase 411 · 2 open
Phase 37 · 0 open
Phase 14 · 0 open
Phase 1/22 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2000; this study’s year is marked. 3 started in 2016.

Size and results

Median enrollment 85 across the 45 interventional studies, 470 across the 32 observational. Of the 64 that completed or were terminated, 24 (38%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 79 studies in Bacteremia with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Enterococcal Bacteremia

Browse trials for

Keywords

  • entercoccal bloodstream infection
  • vancomycin-resistant enterococci
  • vancomycin-susceptible enterococci
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cultures obtained from patients not admitted to the hospital
  • Isolate(s) not available for further studies.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. All-cause, in-hospital mortality

    Death by any cause while patient is in the hospital

    Time frame: 30 days or until hospital discharge

Secondary outcomes

  1. Number of participants with microbiological outcome

    Eradication defined as a negative follow-up blood culture \> 4 days after index blood culture

    Time frame: 7 days after first documented positive blood culture

  2. Number of participants with recurrence of bacteremia

    Positive blood culture with the same organism within the following 14 days after the documented eradication of bacteremia

    Time frame: 14 days after the documented eradication of bacteremia

07

Study locations

11 of 12 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2016 (actual). Primary completion is estimated for May 2025, 105 months after the start.

Of 32 non-industry observational studies under Bacteremia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 105 months is above that.

Counting every sponsor, half of 39 studies reached it within 21 months; a quarter within 11 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2020
First posted
Jun 1, 2020
StartActual
Aug 1, 2016
Primary completionEst.
May 31, 2025
CompletionEst.
Aug 31, 2025
Last update
Jun 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04410276
Responsible party
Cesar A Arias (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jun 1, 2020
Start date
Aug 1, 2016
Primary completion
May 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Jun 1, 2020

Study contacts

Cesar A. Arias, MD, MSc, PhD
Contact
Cesar.Arias@uth.tmc.edu
(713) 500-9000
Truc T. Tran, PharmD
Contact
Truc.T.Tran@uth.tmc.edu
(713) 500-6748
Cesar A. Arias, MD, MSc, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion