CMV Intensive Care Units

CMV Infection Clinical Trial

Official title:

A Prospective Monitoring Study of Cytomegalovirus Infection in Immunocompetent Critical Heart Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324244
• Other study ID #: MICRO.HGUGM.2014-006
• Status: Completed
• Phase: N/A
• First received: November 26, 2014
• Last updated: December 23, 2014
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: December 2014
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Agreeing to participate in the study

• Age of at least 18 years

• Admission to the MHS-ICU for at least 72 hours

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• CMV Infection
• Cytomegalovirus Infections

Locations

Country	Name	City	State
Spain	Servicio de Microbiologia y Enfermedades Infecciosas	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Emilio Bouza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence number of participants with a positive CMV positive result		month 8	No
Secondary	risk factors for CMV reactivation		month 8	No
Secondary	mortality by day 30	composite endpoint. hospitalization or death by day 30	month 8	No
Secondary	prolonged hospitalization . More than 30 days		month 8	No