Actively Recruiting
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
Eligibility Criteria
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
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
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
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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