Using acyclovir to treat pneumonia in ventilated patients with herpes simplex virus
Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage
This study is testing if giving acyclovir to ICU patients on ventilators who have pneumonia and herpes simplex virus can help them survive better than those who don't receive the medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 616 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 28 sites (Freiburg im Breisgau, Baden-Wurttemberg and 27 other locations) |
| Trial ID | NCT06134492 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require respiratory support and have a confirmed HSV-1 infection in BAL.
Not a fit: Patients with a history of hypersensitivity to acyclovir or those currently receiving other antiviral treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in critically ill patients with pneumonia and HSV-1.
How similar studies have performed: Previous retrospective studies have suggested that antiviral treatment may improve outcomes in similar patient populations, indicating potential for success in this prospective trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Simultaneous participation in another interventional clinical trial 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 this trial is running
Freiburg im Breisgau, Baden-Wurttemberg and 27 other locations
- 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)
- Klinikum rechts der Isar — München, Bavaria, Germany (Recruiting)
- Klinikum rechts der Isar — München, Bavaria, Germany (Recruiting)
- Klinikum Nürnberg, Campus Nord — Nuremberg, Bavaria, Germany (Recruiting)
- Klinikum Nürnberg, Campus Süd — Nuremberg, Bavaria, Germany (Recruiting)
- Universitätsklinikum Regensburg — Regensburg, Bavaria, Germany (Recruiting)
- RoMed Klinikum Rosenheim — Rosenheim, Bavaria, Germany (Recruiting)
- Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum — Herne, Nordreihn-Westfalen, Germany (Recruiting)
- Evangelisches Klinikum Bethel — Bielefeld, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Köln AöR — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Münster — Münster, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Dresden — Dresden, Saxony, Germany (Recruiting)
- Universitätsklinikum Leipzig — Leipzig, Saxony, Germany (Recruiting)
- Universitätsklinikum Leipzig — Leipzig, Saxony, Germany (Recruiting)
- Universitätsklinikum Halle — Halle, Saxony-Anhalt, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein Campus Lübeck — Lübeck, Schleswig-Holstein, Germany (Recruiting)
- Universitätsklinikum Jena — Jena, Thuringia, Germany (Recruiting)
- Evangelisches Klinikum Bethel — Bielefeld, Germany (Recruiting)
- Universitätsklinikum Hamburg Eppendorf — Hamburg, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.