Interest of preemptive treatment with ganciclovir or acyclovir in patients requiring prolonged mechanical ventilation and have either a cytomegalovirus replication in blood or an herpes simplex virus oropharyngeal replication: Prospective, multicenter, randomized double-blind

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2013
Trade Name: Cymevan™ 500 mg Product Name: Cymevan Product Code: ganciclovir Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: GANCICLOVIR CAS Number: 82410‐32‐0 Pharmaceutical form of the placebo: Lyophilisate for solution for infusion Route of administration of the placebo: Parenteral use (Noncurrent) Trade Name: ACICLOVIR MYLAN 500 mg Product Name: ACICLOVIR MYLAN Product Code: ACICLOVIR Pharmaceutical Form: Lyophilisate for solution for infusion CAS Number: 59277‐89‐3 Current Sponsor code: ACICLOVIR Other descriptive name: ACICLOVIR Pharmaceutical form of the placebo: Lyophilisate for solution for infusion Route of administration of the placebo: Parenteral use (Noncurrent) Main Objective: Patients mechanically ventilated for at least 96 hours, show that treatment with ganciclovir in patients with CMV replication by acyclovir or in those with HSV replication reduces the duration of mechanical ventilation and an improved prognosis.;Secondary Objective: Mortality to J60 ‐ Mortality in resuscitation ‐ Hospitable(hospital) Mortality ‐ Lasted invasive mechanical ventilation ‐ Lasted hospitalization in resuscitation ‐ Lasted hospitalization ‐ Incidence of the active infections to CMV ‐ Rate of reactivations ‐ Incidence of bronchopneumonies herpétiques ‐ Evolution of the failures of organs to J3, J5, J7, J14, J21 and J28 estimated by the score SOFA;Primary end point(s): Number of alive days without mechanical ventilation to J60 after the randomization.;Timepoint(s) of evaluation of this end point: 3years Secondary end point(s): Mortalities to J60, in resuscitation and hospitable ‐ Lasted total of mechanical ventilation at the survivors ‐ Lasted total of stay in resuscitation and at the hospital ‐ Incidence of the bacterial pneumonias acquired under mechanical ventilation and bactériémies;Timepoint(s) of evaluation of this end point: 3 years
Epistemonikos ID: fc73a8ca998895f9d4401a8a0dee87bf5acfc6ea
First added on: Aug 21, 2024