Active infection with cytomegalovirus (CMV) in critically ill patients on mechanical ventilation with severe sepsis or septic shock MedDRA version: 14.0 Level: PT Classification code 10011831 Term: Cytomegalovirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: CYMEVENE
Product Name: CYMEVENE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: GANCICLOVIR SODIUM
CAS Number: 107910-75-8
Other descriptive name: GANCICLOVIR SODIUM
Concen
Sponsors
FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: ? Patients who are participating in other clinical trials. ? Immunosuppression known at the time of admission ? Neutropenia (neutrophils 2 mg/dL ? Patients who are pregnant or breastfeeding. ? Other contraindications listed in the Summary of ganciclovir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Determine the percentage of patients with negative conversion of CMV in blood and tracheal aspirate at the end of treatment (14 days). That figure is compared with that obtained with placebo.;Timepoint(s) of evaluation of this end point: 2 times per week from the diagnosis of active CMV infection until discharge from ICU.;Main Objective: Determine the efficacy of early administration of ganciclovir against CMV infection, guided by the virological monitoring (presence of viral DNA in respiratory secretions and plasma) in patients with severe sepsis or septic shock admitted to the ICU. Efficacy was assessed by the percentage of patients with negative conversion of CMV in blood and tracheal aspirate at the end of treatment (14 days).;Secondary Objective: -Assess the safety of administration of ganciclovir in these patients in terms of neutropenia (neutrophils <1.0 x 10^9 / L and <0.5 x 10^9 / L). -Evaluate the outcome of patients treated with ganciclovir compared with placebo in terms of days of mechanical ventilation, length of ICU stay, frequency and type of concomitant infections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Assess the safety of the administration of ganciclovir in these patients in terms of neutropenia (neutrophils <1.0 x 10^9 / L and <0.5 x 10^9 / L). To determine this, researchers use in blood tests periodically (every 24 hours) are performed routinely in these patients ? Evaluate the outcome of patients treated with ganciclovir compared with placebo in terms of days of mechanical ventilation, ICU length of stay and type and frequency of concomitant infections (pulmonary, bacteremia, surgical wound infection, urinary);Timepoint(s) of evaluation of this end point: -Every 24 hours -At the end of treatment | — |
Countries
Spain
Contacts
Public ContactUNIDAD ENSAYOS CLINICOS
FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA
Outcome results
None listed