Using acyclovir to treat pneumonia in ventilated patients with herpes simplex virus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of acyclovir in improving outcomes for mechanically ventilated patients diagnosed with pneumonia and detected herpes simplex virus (HSV-1) in their bronchoalveolar lavage (BAL). The study will involve 616 ICU patients who will be randomly assigned to receive either acyclovir or no antiviral therapy for 10 days. The primary endpoint is to assess overall survival within 30 days post-treatment. This multicenter, randomized controlled trial seeks to clarify whether antiviral therapy is necessary in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥ 18 years
2. need for invasive or non-invasive respiratory support
3. PCR HSV-1 detection in BAL (≥ 10\^3 copies/ml)
4. Pneumonia (community or healthcare acquired, incl. ventilator-associated pneumonia)
5. declaration of consent by the patient or legal representative

Exclusion Criteria:

1. History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product.
2. Pregnancy/Lactation 3.3. 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

4.Decision to withhold life-sustaining therapies 5.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.

6.Solid organ transplantation, stem cell transplantation 7.Neutropenia (absolute neutrophil count \<1500/μl (\<1.5 × 109 /l) 8.Previous study participation in HerpMV

Where it's running

• Universitätsklinikum Freiburg
  Freiburg im Breisgau, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Heidelberg
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Heidelberg
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Tübingen
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Augsburg
  Augsburg, Bavaria, Germany Recruiting
• Klinikum der Ludwig-Maximilian-Universität München
  München, Bavaria, Germany Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.