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

Phase 1

Recruiting

• Conditions: Patients in ICU with invasive mechanical ventilation and HSV throat reactivation with 1 or no organ failures.; MedDRA version: 23.0Level: PTClassification code: 10080137Term: Herpes simplex reactivation Class: 100000004862; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

• Registration Number: CTIS2023-505510-26-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

aged = 18 year-old, Invasive 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), 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 Criteria

Hypersensitivity to acyclovir, to valacyclovir or to excipient, Decision of withholding/withdrawing care, Pregnant or breastfeeding (controlled by a urinary or blood pregnancy test), Patient who received an antiviral drug active against HSV (acyclovir, valacyclovir, gancyclovir, valgancyclovir, foscarvir, 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 SAPS II score at inclusion >75 points

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified