RecruitingPhase 3NCT06134492

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

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


Sponsor

Jena University Hospital

Enrollment

616 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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, 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 viruses (e.g. with acyclovir) is necessary in this situation and helps the patients to cure has not been clarified, especially as acyclovir can also cause side effects such as a deterioration in kidney function. Currently, the physicians decide to treat the herpes viruses in about half of the patients. Several studies have shown that patients for whom the physician decided to treat the viruses survived more often. However, all of these studies looked at the course of the disease only retrospectively and thus are subject to many biases (including physician selection of who receives treatment, missing data). A definitive conclusion as to whether herpesvirus therapy can be recommended cannot be drawn without doubt from these studies. Therefore, the investigators would like to investigate in a randomized controlled trial, i.e. patients are randomly assigned to the experimental (therapy of herpesviruses) or control group (no therapy of herpesviruses), the effect of therapy with acyclovir on survival in ventilated intensive care patients with lower respiratory tract infection (pneumonia) in whom a large amount of HSV was found in the respiratory tract. The goal of the study is to provide clarity on whether therapy will help patients recover.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • ≥ 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 Criteria8

  • 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

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Interventions

DRUGAcyclovir

Dosage: 10mg/kg (current) body weight every 8 hours, dose adjustment to renal function according to technical information. Mode of administration: intravenous (i.v.)


Locations(28)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Augsburg

Augsburg, Bavaria, Germany

Klinikum der Ludwig-Maximilian-Universität München

München, Bavaria, Germany

Klinikum rechts der Isar

München, Bavaria, Germany

Klinikum rechts der Isar

München, Bavaria, Germany

Klinikum Nürnberg, Campus Nord

Nuremberg, Bavaria, Germany

Klinikum Nürnberg, Campus Süd

Nuremberg, Bavaria, Germany

Universitätsklinikum Regensburg

Regensburg, Bavaria, Germany

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, Germany

Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum

Herne, Nordreihn-Westfalen, Germany

Evangelisches Klinikum Bethel

Bielefeld, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Köln AöR

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Universitätsklinikum Dresden

Dresden, Saxony, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Universitätsklinikum Jena

Jena, Thuringia, Germany

Evangelisches Klinikum Bethel

Bielefeld, Germany

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

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NCT06134492


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