This research aims to assess the interest of preemptive treatment with Acyclovir in mechanically ventilated patients with reactivation of Herpes simplex (HSV) in the throat and failure of one organ or less. HSV reactivation is common in patients hospitalized in an intensive care unit (ICU) on invasive mechanical ventilation. It begins at the oropharyngeal level (incidence up to 20-50%), then progresses downward with contamination of the distal airways (reported incidence of 20-65%). HSV reactivation is associated with high mortality. The investigators aim to disable that, in mechanically ventilated patients with HSV reactivation in the throat and failure of one organ or less, preemptive treatment with Acyclovir may reduce mortality.
To answer the question posed in the research, it is planned to include 246 people hospitalized in intensive care on invasive mechanical ventilation, presenting with HSV reactivation of the throat and one organ failure or less.
aged ≥ 18 year-old
invasive mechanical ventilation(MV) for 96 hours and planned to last for at least 48 hours longer
HSV reactivation in the throat (qualitative PCR positive for HSV on a throat swab)
Presence of 1 or less organ failure; organ failure being defined as a corresponding-organ SOFA score of 3 or 4 (for example, renal failure will be defined as a renal SOFA score of 3 or 4)
Hypersensitivity to acyclovir and excipient
Pregnant or breastfeeding (controlled by a blood pregnancy test)
Patient who received an antiviral drug active against HSV (acyclovir, valacyclovir, gancyclovir, valgancyclovir, foscavir, cidofovir) in the previous 30 days
Duration of ventilation before randomization >15 days
Parallel
Intravenous acyclovir (ACYCLOVIR )
DrugPatients randomized in the experimental arm will receive intravenous acyclovir at a dosing of 5 mg/kg/8 hours during 14 days (treatment will be stopped at ICU discharge).
Saline bags
DrugPatients randomized in the control arm will receive placebo, eg. saline bags (same volume as acyclovir bags) every 8 hours during 14 days (treatment will be stopped in case of ICU discharge).
Mortality
Primary endpoint will be the mortality at day 60 post randomization
Mortality
Day 90
Duration of mechanical ventilation
Duration of mechanical ventilation, either invasive or non-invasive, from randomization to extubation or death, whichever first occurs
Ventilator-free days at day 60
Measured as the number of day alive and without mechanical ventilation (invasive mechanical ventilation or non-invasive mechanical ventilation) from randomization to day 60 post-randomization. Patients dying before day 60 will have zero ventilator-free days.
ICU length of stay
Measured by the number of day in the ICU from randomization to ICU discharge or death
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