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Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06134492

Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage

Led by Jena University Hospital · Updated on 2025-11-21

616

Participants Needed

28

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Herpes simplex viruses HSV are very common, affecting nearly 90 of people, and stay in the body for life in a dormant state. When the immune system is weakened, HSV can reactivate and cause infections like cold sores or more serious conditions such as meningitis. In intensive care patients on mechanical ventilation with pneumonia, HSV is often detected in the respiratory tract. This research aims to determine whether treating HSV with acyclovir improves survival in these critically ill patients. The study randomly assigns 616 ventilated ICU patients with pneumonia and HSV detected in their lung fluid to receive either acyclovir treatment or no antiviral therapy. Acyclovir is given intravenously at a dose of 10 mg per kg of body weight every 8 hours for up to 10 days or until ICU discharge if earlier. The trial compares survival rates after 30 days between the two groups and also looks at ventilation-free days, vasopressor-free days, and safety outcomes. Participants will be closely monitored during the study with regular assessments including organ function scores, kidney function tests, microbiological cure, length of ICU and hospital stay, and quality of life measures up to 180 days. Safety will be tracked by recording serious adverse events. This comprehensive evaluation will help clarify whether antiviral therapy benefits ventilated patients with pneumonia and HSV in their lungs.

CONDITIONS

Brief Title

Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Need for invasive or non-invasive respiratory support
  • HSV-1 detection in bronchoalveolar lavage with at least 1,000 copies/ml by PCR
  • Pneumonia including community-acquired, hospital-acquired, or ventilator-associated pneumonia
  • Provided informed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • History of allergic reaction to acyclovir, valacyclovir, or related components
  • Pregnant or breastfeeding women
  • Participation in another interventional clinical trial at the same time
  • Decision made to withhold life-sustaining therapies
  • Current use of antiviral drugs active against herpes simplex for treatment or prevention
  • History of solid organ or stem cell transplantation
  • Neutropenia with absolute neutrophil count below 1,500/µl
  • Previous participation in the HerpMV study

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