Patients in ICU with invasive mechanical ventilation and HSV throat reactivation with 1 or no organ failures.
Conditions
Brief summary
Primary endpoint will be the mortality at day 60 post randomization
Detailed description
Day-90 mortality., Duration of mechanical ventilation and ventilator-free days at day 60., ICU length of stay and ICU-free days at day 60., Hospital length of stay and hospital-free days at day 60., SOFA score at days 1, 3, 5, 7, 10, 14, 21 and 28 post randomization., Incidence of HSV oral-labial lesions from randomization to day 28., Rate of patients with HSV positive in the throat at days 3, 7, 10, 14, 17, 21 and 28 post randomization., Rate of patients with HSV positive in tracheal aspirate at days 1, 7, 14, 21 and 28 post randomization., Rate of HSV bronchopneumonitis from randomization to day 60 post-randomization, Rate of acute respiratory distress syndrome (according to Berlin criteria) from randomization to day 60., Rate of bacterial ventilator-associated pneumonia from randomization to day 60., Rate of bacteremia from randomization to day 60., Glasgow coma score at days 1, 3, 5, 7, 10, and 14 post-randomization., Creatinine clearance at days 1, 3, 5, 7, 10, 14, 21 and 28 post randomization and need for renal replacement therapy and RRT free days from randomization to day 14 (acyclovir toxicity), Incidence of adverse event, severe adverse event at days 1, 3, 5, 7, 10, 14, 21 and 28 post randomization.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the mortality at day 60 post randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Day-90 mortality., Duration of mechanical ventilation and ventilator-free days at day 60., ICU length of stay and ICU-free days at day 60., Hospital length of stay and hospital-free days at day 60., SOFA score at days 1, 3, 5, 7, 10, 14, 21 and 28 post randomization., Incidence of HSV oral-labial lesions from randomization to day 28., Rate of patients with HSV positive in the throat at days 3, 7, 10, 14, 17, 21 and 28 post randomization., Rate of patients with HSV positive in tracheal aspirate at days 1, 7, 14, 21 and 28 post randomization., Rate of HSV bronchopneumonitis from randomization to day 60 post-randomization, Rate of acute respiratory distress syndrome (according to Berlin criteria) from randomization to day 60., Rate of bacterial ventilator-associated pneumonia from randomization to day 60., Rate of bacteremia from randomization to day 60., Glasgow coma score at days 1, 3, 5, 7, 10, and 14 post-randomization., Creatinine clearance at days 1, 3, 5, 7, 10, 14, 21 and 28 post | — |
Countries
France