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HerpMV
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 study identifier
Secondary identifiers
OTHER_GRANT · Federal Ministry of Education and Research
interventional
616
1 country
28
Study Start
February 20, 2024
Actual (reported)Primary Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2023
Actual (reported)November 18, 2023
Actual (reported)February 20, 2024
Actual (reported)July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
mortality (survival status)
survival status
day 30
Ventilation-free days
day 30
Vasopressor-free days
day 30
Delta SOFA score (Sepsis-related Organ Failure Assessment Score)
Baseline - Day 10 or EOT if this event occurs earlier
Aciclovir therapy
No study-specific treatment measures
Dosage: 10mg/kg (current) body weight every 8 hours, dose adjustment to renal function according to technical information. Mode of administration: intravenous (i.v.)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Hagel S, Brillinger N, Decker S, Deja M, Ertmer C, Fiedler S, Franken P, Heim M, Weigand MA, Zarbock A, Pletz MW; SepNet Critical Care Trials Group. Effect of acyclovir therapy on the outcome of mechanically ventilated patients with lower respiratory tract infection and detection of herpes simplex virus in bronchoalveolar lavage: protocol for a multicentre, randomised controlled trial (HerpMV). BMJ Open. 2024 Apr 25;14(4):e082512. doi: 10.1136/bmjopen-2023-082512.
First Submitted
November 1, 2023
First Posted
November 18, 2023
Study Start
February 20, 2024
Actual (reported)Primary Completion
July 2026
Estimated (date passed)Delta SOFA sub-score kidney (Sepsis-related Organ Failure Assessment Score)
Baseline - Day 10 or EOT if this event occurs earlier
Delta GFR value
Baseline - Day 10 or EOT if this event occurs earlier
Contact the study team to confirm eligibility.
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156, Germany
Klinikum der Ludwig-Maximilian-Universität München
München, Bavaria, 81377, Germany
Klinikum rechts der Isar
München, Bavaria, 81675, Germany
Klinikum rechts der Isar
München, Bavaria, 81675, Germany
Klinikum Nürnberg, Campus Nord
Nuremberg, Bavaria, 90419, Germany
Klinikum Nürnberg, Campus Süd
Nuremberg, Bavaria, 90471, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053, Germany
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, 83022, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum
Herne, Nordreihn-Westfalen, 44625, Germany
Evangelisches Klinikum Bethel
Bielefeld, North Rhine-Westphalia, 33617, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Universitätsklinikum Köln AöR
Cologne, North Rhine-Westphalia, 50937, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum Dresden
Dresden, Saxony, 01307, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 06120, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Schleswig-Holstein, 23538, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Evangelisches Klinikum Bethel
Bielefeld, 33611, Germany
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 23, 2026
Record last verified: 2025-11
Results will be published in a journal indexed in MEDLINE and CTIS; there are no publication restrictions. After publication, deidentified, individual participant data that underlie this trial, along with a data dictionary describing variables in the dataset, will be made available to researchers whose proposed purpose of use is approved by the Trial Management Team.
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Source: ClinicalTrials.gov.
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