Status:
RECRUITING
Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL
Lead Sponsor:
Jena University Hospital
Conditions:
Pneumonia, Viral
Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Almost 90 out of 100 people carry herpes simplex viruses (HSV). Once a person has been infected with the herpes viruses, he or she can't get rid of them for the rest of her/his life. For the most part...
Detailed Description
Herpes-simplex virus (HSV) can be detected in the bronchoalveolar lavage (BAL) in up to 60% of mechanically ventilated (MV) ICU patients with a lower respiratory tract infection (LRTI), depending on t...
Eligibility Criteria
Inclusion
- ≥ 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
Exclusion
- History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product.
- Pregnancy/Lactation
- Simultaneous participation in another interventional clinical trial
- 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
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
616 Patients enrolled
Trial Details
Trial ID
NCT06134492
Start Date
February 20 2024
End Date
December 1 2026
Last Update
November 21 2025
Active Locations (28)
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1
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
4
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076