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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
Other Locations
Germany
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Evangelisches Klinikum Bethel
RECRUITING
Bielefeld
Universitätsklinikum Bonn
RECRUITING
Bonn
Universitätsklinikum Köln AöR
RECRUITING
Cologne
Universitätsklinikum Dresden
RECRUITING
Dresden
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Universitätsklinikum Essen
RECRUITING
Essen
Universitätsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Halle
RECRUITING
Halle
Universitätsklinikum Hamburg Eppendorf
RECRUITING
Hamburg
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum
RECRUITING
Herne
Universitätsklinikum Jena
RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein Campus Kiel
RECRUITING
Kiel
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Schleswig-Holstein Campus Lübeck
RECRUITING
Lübeck
Klinikum der Ludwig-Maximilian-Universität München
RECRUITING
München
Klinikum rechts der Isar
RECRUITING
München
Klinikum rechts der Isar
RECRUITING
München
Universitätsklinikum Münster
RECRUITING
Münster
Klinikum Nürnberg, Campus Nord
RECRUITING
Nuremberg
Klinikum Nürnberg, Campus Süd
RECRUITING
Nuremberg
Universitätsklinikum Regensburg
RECRUITING
Regensburg
RoMed Klinikum Rosenheim
RECRUITING
Rosenheim
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 616
Treatments
Experimental: Treatment group
Aciclovir therapy
No_intervention: Comparison group
No study-specific treatment measures
Sponsors
Leads: Jena University Hospital

This content was sourced from clinicaltrials.gov