Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes (PTH2)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intravenous acyclovir (ACYCLOVIR )
  • Saline bags

Treatment groups

246 Participants
are divided into 2 treatment groups

Locations

This trial has no locations