Enterococcal BacteremiaNCT04410276
VENOUS: A Translational Study of Enterococcal Bacteremia
An observational study of Enterococcal Bacteremia, run by The University of Texas Health Science Center, Houston at 12 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterococcal Bacteremia
- How many people
- 1,000 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 1 Aug 2016to 31 Aug 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients
Who may be able to join
- 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
Who cannot join
- Cultures obtained from patients not admitted to the hospital
- Isolate(s) not available for further studies.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
United States8 sites, 8 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
David van Duin, MD, PhD, David_vanduin@med.unc.edu
- Recruiting
Henry Ford Hospital and Medical Centers
Detroit, Michigan, 48202
Katherine Reyes, MD, PhD, Kreyes1@hfhs.org
Marcus Zeryos, MD, mzervos@hfhs.org
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Samuel Shelburne, MD, PhD, sshelburne@mdanderson.org
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Cesar A. Arias, MD, MSc, PhD, 713-500-9000, Cesar.Arias@uth.tmc.edu
Truc T. Tran, PhD, (713) 500-6748, Truc.T.Tran@uth.tmc.edu
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Luis Shimose, MD, lshimoseciudad@umc.edu
- Recruiting
Jackson Health System, University of Miami Miller School of Medicine
Miami, Florida, 33136
Lilian Abbo, MD, labbo@med.miami.edu
- Recruiting
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Yohei Doi, MD, PhD, yod4@pitt.edu
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Catherine Liu, MD, Catherine.liu@fredhutch.org
Argentina1 site, 1 recruiting
- Recruiting
Hospital Sanatorio
Buenos Aires
Fernanda Barberis, MD, ferbarberis@hotmail.com
Chile1 site, 1 recruiting
- Recruiting
Hospital Padre Hurtado
Santiago
José M. Munita, MD, Jose.m.munita@uth.tmc.edu
Germany1 site, 1 recruiting
- Not yet recruiting
University of Cologne
Cologne
Harald Seifert, MD, harald.seifert@uni-koeln.de
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
Barcelona
Carlota Guidiol, MD, carlotasway@hotmail.com
About this study
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
- Keywords
- entercoccal bloodstream infection, vancomycin-resistant enterococci, vancomycin-susceptible enterococci
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause, in-hospital mortality
Death by any cause while patient is in the hospital
Measured: 30 days or until hospital discharge
Secondary outcomes (2)
Number of participants with microbiological outcome
Eradication defined as a negative follow-up blood culture > 4 days after index blood culture
Measured: 7 days after first documented positive blood culture
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
Measured: 14 days after the documented eradication of bacteremia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Aug 2016
- Primary completion31 May 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterococcal BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar A Arias, The University of Texas Health Science Center, Houston
- Investigators
- Cesar A. Arias, MD, MSc, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410276
- Sponsor's protocol ID
- HSC-MS-15-0055
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VENOUS: A Translational Study of Enterococcal Bacteremia
- ClinicalTrials.gov ID
- NCT04410276
- Acronym / sponsor ID
- HSC-MS-15-0055
- Conditions
- Enterococcal Bacteremia
- Keywords
- entercoccal bloodstream infection, vancomycin-resistant enterococci, vancomycin-susceptible enterococci
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cultures obtained from patients not admitted to the hospital
- Isolate(s) not available for further studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause, in-hospital mortality
Time frame: 30 days or until hospital discharge
Death by any cause while patient is in the hospital
2 secondary outcomes
Number of participants with microbiological outcome
Time frame: 7 days after first documented positive blood culture
Number of participants with recurrence of bacteremia
Time frame: 14 days after the documented eradication of bacteremia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar A. Arias, MD, MSc, PhD principal investigator
The University of Texas Health Science Center, Houston
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterococcal Bacteremia, run by The University of Texas Health Science Center, Houston at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Argentina, Chile, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cesar A. Arias, MD, MSc, PhD ((713) 500-9000, Cesar.Arias@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause, in-hospital mortality (time frame: 30 days or until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.