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

RecruitingPhase 3Ages 18 Years - anyAllJena University Hospital
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In plain words

What the trial is, and whether it could suit you

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, the viruses are in a dormant state. Only when the immune system is weakened, for example in the case of a serious illness or stress, are the viruses reactivated. They then mainly cause cold sores, which are harmless for healthy people and usually heal without therapy. However, especially in people with a weakened immune system, HSV can also cause serious infections, such as meningitis. In almost every second mechanically ventilated patient in intensive care who has pneumonia, HSV can be detected in the respiratory tract. This is caused by reactivation of the viruses as a result of the severe underlying disease and stress during intensive care therapy. Whether treatment of the herpes viruse

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📋 Eligibility rules (as published)
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
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What it tests

  • Acyclovir
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Where

28 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Augsburg
Augsburg, Germany
Klinikum der Ludwig-Maximilian-Universität München
München, Germany
Klinikum rechts der Isar
München, Germany
Klinikum rechts der Isar
München, Germany

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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