NCT02324244

Brief Summary

Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

November 26, 2014

Last Update Submit

December 23, 2014

Conditions

CMV Infection

Keywords

Cytomegaloviruscritical patientICUimmunocompetentclinical suspicionrisk factors

Outcome Measures

Primary Outcomes (1)

  • incidence number of participants with a positive CMV positive result

    month 8

Secondary Outcomes (3)

  • risk factors for CMV reactivation

    month 8

  • mortality by day 30

    month 8

  • prolonged hospitalization . More than 30 days

    month 8

Study Arms (1)

immunocompetent patients underwent heart surgery

Eligibility Criteria

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

immunocompetent adults admitted to a major heart surgery intensive care unit

You may qualify if:

  • Agreeing to participate in the study
  • Age of at least 18 years
  • Admission to the MHS-ICU for at least 72 hours

You may not qualify if:

  • Inability to give informed consent
  • Age younger than 18 years
  • AIDS
  • Pregnancy
  • Organ or bone marrow transplant, receipt of immunosuppressive therapy including corticosteroids within 30 days, and cancer or hematologic malignancy treated with radiotherapy or chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Microbiologia y Enfermedades Infecciosas

Madrid, Madrid, 28007, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma samples

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Patricia Muñoz, PhD

    Hospital General Universitario Gregorio Marañon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 24, 2014

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

ES(1)