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

NCT06134492 | Recruiting Phase 3 DMC

• 2 other identifiers: ZKSJ0153BMBF 01KG2301
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 28

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, 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.

Conditions

Pneumonia, Viral; Ventilator Associated Pneumonia; Community-acquired Pneumonia; Herpes Simplex; Hospital-acquired Pneumonia

Keywords

Pneumonia; Herpes Simplex; Mechanical Ventilation; Aciclovir

Outcome Measures

Primary Outcomes (1)

• mortality (survival status)

  survival status

  day 30

Secondary Outcomes (14)

• 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

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Aciclovir therapy

Drug: Acyclovir

Comparison group

NO INTERVENTION

No study-specific treatment measures

Interventions

Acyclovir DRUG

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

Also known as: Aciclovir

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (28)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Universitätsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Klinikum der Ludwig-Maximilian-Universität München

München, Bavaria, 81377, Germany

RECRUITING

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Klinikum Nürnberg, Campus Nord

Nuremberg, Bavaria, 90419, Germany

RECRUITING

Klinikum Nürnberg, Campus Süd

Nuremberg, Bavaria, 90471, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, 83022, Germany

RECRUITING

Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum

Herne, Nordreihn-Westfalen, 44625, Germany

RECRUITING

Evangelisches Klinikum Bethel

Bielefeld, North Rhine-Westphalia, 33617, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Universitätsklinikum Köln AöR

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Universitätsklinikum Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitätsklinikum Halle

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

RECRUITING

Evangelisches Klinikum Bethel

Bielefeld, 33611, Germany

RECRUITING

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 38670599 DERIVED

Related Links

• Study protocol

MeSH Terms

Conditions

Pneumonia, Viral; Pneumonia, Ventilator-Associated; Community-Acquired Pneumonia; Herpes Simplex; Healthcare-Associated Pneumonia; Pneumonia

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Herpesviridae Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 18, 2023
• Study Start: February 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication

Locations

DE (28)