Study for the treatment of cytomegalovirus infection in critically ill patients on mechanical ventilatio

• Conditions: Active infection with cytomegalovirus (CMV) in critically ill patients on mechanical ventilation with severe sepsis or septic shock; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 14.0Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-002603-15-ES
• Lead Sponsor: FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? Signing the informed consent (patient or family)
? Age equal or greater than 18 years
? Positive serology for CMV (IgG and/or IgM) at the time of admission
? active CMV infection during their ICU stay (> 10 CMV DNA copies/ml of tracheal aspirate and/or peripheral blood).
? Severe sepsis or septic shock (it will follow the definitions of the consensus conference) requiring mechanical ventilation.
? Women of childbearing potential must test negative serum or urine test and use effective contraception.
? Admitted to ICU
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

? Patients who are participating in other clinical trials.
? Immunosuppression known at the time of admission
? Neutropenia (neutrophils <500/?l)
? Thrombocytopenia (<25x10^9/L)
? Liver failure: bilirubin>2 mg/dL
? Patients who are pregnant or breastfeeding.
? Other contraindications listed in the Summary of ganciclovir

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified