Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06134492

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

Led by Jena University Hospital · Updated on 2025-11-21

616

Participants Needed

28

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Need for invasive or non-invasive respiratory support
  • PCR detection of HSV-1 in bronchoalveolar lavage with at least 10,000 copies/ml
  • Diagnosis of pneumonia (community-acquired, healthcare-associated, or ventilator-associated)
  • Provided consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • History of allergic reaction to acyclovir, valacyclovir, or any study drug components
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial at the same time
  • Decision made to withhold life-sustaining treatments
  • Current use of antiviral drugs active against herpes simplex virus for treatment or prevention
  • History of solid organ or stem cell transplantation
  • Neutropenia with absolute neutrophil count below 1500/µl
  • Previous participation in the HerpMV study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106

Actively Recruiting

2

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

3

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

4

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

5

Universitätsklinikum Augsburg

Augsburg, Bavaria, Germany, 86156

Actively Recruiting

6

Klinikum der Ludwig-Maximilian-Universität München

München, Bavaria, Germany, 81377

Actively Recruiting

7

Klinikum rechts der Isar

München, Bavaria, Germany, 81675

Actively Recruiting

8

Klinikum rechts der Isar

München, Bavaria, Germany, 81675

Actively Recruiting

9

Klinikum Nürnberg, Campus Nord

Nuremberg, Bavaria, Germany, 90419

Actively Recruiting

10

Klinikum Nürnberg, Campus Süd

Nuremberg, Bavaria, Germany, 90471

Actively Recruiting

11

Universitätsklinikum Regensburg

Regensburg, Bavaria, Germany, 93053

Actively Recruiting

12

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, Germany, 83022

Actively Recruiting

13

Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum

Herne, Nordreihn-Westfalen, Germany, 44625

Actively Recruiting

14

Evangelisches Klinikum Bethel

Bielefeld, North Rhine-Westphalia, Germany, 33617

Actively Recruiting

15

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

16

Universitätsklinikum Köln AöR

Cologne, North Rhine-Westphalia, Germany, 50937

Actively Recruiting

17

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Actively Recruiting

18

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany, 45147

Actively Recruiting

19

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany, 48149

Actively Recruiting

20

Universitätsklinikum Dresden

Dresden, Saxony, Germany, 01307

Actively Recruiting

21

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany, 04103

Actively Recruiting

22

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany, 04103

Actively Recruiting

23

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany, 06120

Actively Recruiting

24

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, Germany, 24105

Actively Recruiting

25

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Schleswig-Holstein, Germany, 23538

Actively Recruiting

26

Universitätsklinikum Jena

Jena, Thuringia, Germany, 07747

Actively Recruiting

27

Evangelisches Klinikum Bethel

Bielefeld, Germany, 33611

Actively Recruiting

28

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany, 20246

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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