Status:
NOT_YET_RECRUITING
Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes (PTH2)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Invasive Mechanical Ventilation
HSV Throat Reactivation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Herpes simplex virus (HSV) reactivations are frequent in intensive care unit (ICU) patients receiving invasive mechanical ventilation. HSV reactivation first occurs in the throat (incidence up to 20-5...
Eligibility Criteria
Inclusion
- 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)
- Effective contraception for patients of childbearing age, throughout the treatment period
- Written consent from the patient, from a close relative or from the person of trust previously appointed (or inclusion procedure in emergency situations)
- Under social security cover
Exclusion
- 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
- Neutropenia, defined by an absolute neutrophils count \< 1,000/mm3
- Solid organ or bone-marrow transplant
- Immunosuppressive treatment (including steroids at a dose \>0.5 mg/kg/day of prednisone or equivalent for \>1 month)
- HIV infection
- Moribund, defined by a Simplified Acute Physiology Score (SAPS) II score at inclusion \>75 points
- Decision of withholding/withdrawing care
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT06217406
Start Date
March 1 2024
End Date
March 1 2027
Last Update
January 22 2024
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