Skip to content

Preemptive Treament with acyclovir in intubated and mechanically ventilated patients with Herpes simplex virus oropharyngeal reactivation and one or less organ failure (PTH2)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505510-26-00
Acronym
APHP220800
Enrollment
246
Registered
2024-01-30
Start date
2024-06-19
Completion date
Unknown
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients in ICU with invasive mechanical ventilation and HSV throat reactivation with 1 or no organ failures.

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

DRUGACICLOVIR VIATRIS 500 mg
DRUGCHLORURE DE SODIUM 0

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary endpoint will be the mortality at day 60 post randomization

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026