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Preemptive Treament with acyclovir in intubated and mechanically ventilated patients with Herpes simplex virus oropharyngeal reactivation and one or less organ failure (PTH2)
EU CTIS ID: 2023-505510-26-00
What this study is testing
The primary objective is to show that, in mechanically-ventilated patients hospitalized in the ICU with HSV throat reactivation and 1 organ failure or less, a treatment with acyclovir reduces mortality at day 60 as compared to a placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.