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Effect of acyclovir therapy on the outcome of ventilated patients with lower respiratory tract infection and detection of herpes simplex virus in bronchoalveolar lavage
EU CTIS ID: 2023-504322-19-00
What this study is testing
Testing the impact of the intervention on mortality (30-day mortality).
- 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
- ≥ 18 years
- need for invasive or non-invasive respiratory support
- PCR HSV-1 detection in BAL (≥ 10^3 copies/ml)
- Pneumonia (community or healthcare acquired incl. ventilator-associated pneumonia)
- declaration of consent by the patient or legal representative.
You likely can't join if
- History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product
- Pregnancy/Lactation
- Simultaneous participation in another clinical interventional trial under EU Regulation 536/2014, the German Medicines Act (AMG), Medical Devices Regulation (MDR), or Medical Devices Act (MPDG) without prior consultation and approval by the respective sponsors prior to randomization
- Decision to withhold life-sustaining therapies
- Use of a virostatic agent (i.v. or p. os) with activity against herpes simplex (acyclovir, valacyclovir, famciclovir/penciclovir, brivudine, cidofovir, foscarnet) for therapeutic or prophylactic reasons at the time of randomization
- Solid organ transplantation, stem cell transplantation
See the full eligibility criteria
- ≥ 18 years
- need for invasive or non-invasive respiratory support
- PCR HSV-1 detection in BAL (≥ 10^3 copies/ml)
- Pneumonia (community or healthcare acquired incl. ventilator-associated pneumonia)
- declaration of consent by the patient or legal representative.
- History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product
- Pregnancy/Lactation
- Simultaneous participation in another clinical interventional trial under EU Regulation 536/2014, the German Medicines Act (AMG), Medical Devices Regulation (MDR), or Medical Devices Act (MPDG) without prior consultation and approval by the respective sponsors prior to randomization
- Decision to withhold life-sustaining therapies
- Use of a virostatic agent (i.v. or p. os) with activity against herpes simplex (acyclovir, valacyclovir, famciclovir/penciclovir, brivudine, cidofovir, foscarnet) for therapeutic or prophylactic reasons at the time of randomization
- Solid organ transplantation, stem cell transplantation
- Neutropenia (absolute neutrophil count <1500/μl (<1.5 × 109 /l)
- Previous study participation in HerpMV
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.