Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06134492

Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage

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

616

Participants Needed

28

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Herpes simplex viruses (HSV) are very common, affecting nearly 90% of people, and stay in the body for life in a dormant state. When the immune system is weakened, HSV can reactivate and cause infections like cold sores or more serious conditions such as meningitis. In intensive care patients on mechanical ventilation with pneumonia, HSV is often detected in the respiratory tract. This research aims to determine whether treating HSV with acyclovir improves survival in these critically ill patients. The study randomly assigns 616 ventilated ICU patients with pneumonia and HSV detected in their lung fluid to receive either acyclovir treatment or no antiviral therapy. Acyclovir is given intravenously at a dose of 10 mg per kg of body weight every 8 hours for up to 10 days or until ICU discharge if earlier. The trial compares survival rates after 30 days between the two groups and also looks at ventilation-free days, vasopressor-free days, and safety outcomes. Participants will be closely monitored during the study with regular assessments including organ function scores, kidney function tests, microbiological cure, length of ICU and hospital stay, and quality of life measures up to 180 days. Safety will be tracked by recording serious adverse events. This comprehensive evaluation will help clarify whether antiviral therapy benefits ventilated patients with pneumonia and HSV in their lungs.

CONDITIONS

Brief 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...

  • At least 18 years old
  • Need for invasive or non-invasive respiratory support
  • HSV-1 detection in bronchoalveolar lavage with at least 1,000 copies/ml by PCR
  • Pneumonia including community-acquired, hospital-acquired, or ventilator-associated pneumonia
  • Provided informed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • History of allergic reaction to acyclovir, valacyclovir, or related components
  • Pregnant or breastfeeding women
  • Participation in another interventional clinical trial at the same time
  • Decision made to withhold life-sustaining therapies
  • Current use of antiviral drugs active against herpes simplex for treatment or prevention
  • History of solid organ or stem cell transplantation
  • Neutropenia with absolute neutrophil count below 1,500/µl
  • Previous participation in the HerpMV study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 days or until discharge from ICU, whichever is earlier

Participants receive acyclovir therapy or no antiviral therapy while in the ICU to evaluate the effect on survival and other clinical outcomes.

Daily visits during treatment period

Follow-up

Duration - Up to 180 days

Participants are monitored after treatment to assess survival status and quality of life up to 180 days.

Visits at day 10 (or end of treatment), day 30, day 90, and day 180

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

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Lung Barometric Measurements in Normal And in Respiratory Di...

Ventilator-Induced Lung Injury

Actively Recruiting

1 location

Prospective Observational Post Marketing Surveillance Study ...

Complicated Intra-abdominal Infection

Actively Recruiting

1 location

Artificial Intelligence Based System for Assessing Suspected...

Pneumonia, Viral

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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).

Stefan Hagel, Nicole Brillinger, Sebastian Decker...

https://pubmed.ncbi.nlm.nih.gov/38670599