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Study on the Effect of Acyclovir in ICU Patients with Pneumonia and Herpes Simplex Virus Type 1 Detected in Lung Fluid

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What is this study about?

This clinical trial is focused on patients who are in the intensive care unit and require ventilation due to a type of lung infection known as pneumonia. The study is particularly interested in cases where the herpes simplex virus type 1 (HSV-1) is found in the lungs. The treatment being tested is called acyclovir, which is given through an infusion directly into the bloodstream. Acyclovir is an antiviral medication that is commonly used to treat infections caused by viruses.

The purpose of the study is to understand how acyclovir affects the health outcomes of these patients, specifically looking at survival rates over a 30-day period. Participants in the study will receive either acyclovir or a placebo, and their progress will be monitored over time. The study will also track other factors such as the number of days patients can breathe without the help of a machine, the length of their stay in the hospital, and their overall quality of life during and after the treatment.

Throughout the study, researchers will collect data to see if acyclovir helps reduce the presence of HSV-1 in the lungs and improves the patients’ recovery. The study aims to provide valuable insights into the potential benefits of using acyclovir for patients with pneumonia and HSV-1, ultimately helping to improve treatment strategies for these serious conditions.

1 joining the study

Participation begins after meeting specific criteria: age 18 or older, requiring respiratory support, detection of herpes simplex virus type 1 in bronchoalveolar lavage, and having pneumonia. Consent must be provided by the patient or a legal representative.

2 treatment administration

The treatment involves the administration of aciclovir, a medication given intravenously. The dosage and frequency are determined by the medical team based on individual needs.

3 monitoring and assessment

Throughout the trial, various health parameters are monitored. These include the number of days without the need for ventilation, days without vasopressor medication, and changes in organ function scores. The length of stay in the intensive care unit and hospital is also recorded.

4 evaluation of outcomes

The primary outcome measured is the 30-day survival rate. Secondary outcomes include the number of days without delirium or coma, microbiological cure, and quality of life assessments at different intervals up to 180 days.

5 completion of the trial

The trial is expected to conclude by December 31, 2026. Final assessments will include long-term survival rates and overall quality of life.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must need help with breathing, either through a machine or other support.
  • Must have a test showing herpes simplex virus type 1 (HSV-1) in the lungs, with at least 1,000 copies per milliliter.
  • Must have pneumonia, which is an infection in the lungs. This can be caught from the community or healthcare settings, including when on a breathing machine.
  • Must have consent given by the patient or their legal representative, which means agreeing to participate in the study.

Who Cannot Join the Study?

  • Patients who are not in the intensive care unit.
  • Patients who are not on a ventilator.
  • Patients who do not have pneumonia.
  • Patients who do not have the herpes simplex virus type 1 (HSV-1) detected in their bronchoalveolar lavage (BAL). The BAL is a test that involves washing out the lungs to collect a sample for testing.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specific clinical trial group required for the study.
  • Patients who are not considered part of a vulnerable population.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
University Hospital Jena KöR Jena Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Romed Klinikum Rosenheim Rosenheim Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Myoywvevdyfydfngqvwzxmqsqw Hftzogxmdmnnceec Halle (Saale) Germany
Udzyaoawwwgozlfpmtcwh Axehryjs Augsburg Germany
Myqdgi Hkcjuyyi Hpuko Unqaedojmqpwnojrzroa dmq Rbcdjkgbliltaphj Bojtch Herne Germany
Ukmycvwttf Hqpmfwes Cwbtarw Cologne Germany
Uidxgamotpplyvvmkxjun Djghpbguued Ahz Duesseldorf Germany
Ktodlfvx dzr Uafjsprqgpft Mnaxhcdm Aou Munich Germany
Uczspzvpfr Muqresc Cmktdp Hcshgnvhdjsqimzac Hamburg Germany
Ujneujtajrgwwrtmqboqd Elxoo Afw Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.12.2023

Trial locations

Investigated drugs:

Acyclovir is a medication used in this clinical trial to treat patients with lower respiratory tract infections who are on ventilators. The trial is investigating whether using acyclovir can improve the outcomes for these patients, specifically looking at whether it can reduce the 30-day mortality rate. Acyclovir is commonly used to treat infections caused by the herpes simplex virus, and in this study, it is being tested to see if it can help patients with respiratory infections where the herpes simplex virus is detected in their lungs.

Investigated diseases:

Pneumonia – Pneumonia is an infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus. It can be caused by bacteria, viruses, or fungi, and leads to symptoms such as cough, fever, chills, and difficulty breathing. The disease can range from mild to severe, with progression depending on the individual’s health and the type of organism causing the infection. In severe cases, especially in hospitalized patients, pneumonia can lead to complications like respiratory failure. It is particularly concerning in patients who are already on ventilation, as it can exacerbate their condition.

Herpes Simplex Virus Type 1 (HSV-1) Infection – HSV-1 is a common virus that typically causes oral herpes, leading to cold sores or fever blisters around the mouth. However, it can also infect other parts of the body, including the respiratory tract, especially in individuals with weakened immune systems. In the context of intensive care units, HSV-1 can be detected in the bronchoalveolar lavage of patients, indicating a possible respiratory infection. The virus can remain dormant in the body and reactivate under certain conditions, leading to recurrent symptoms. Its presence in the respiratory system can complicate the clinical picture, particularly in patients with existing lung conditions.

Trial ID:
2023-504322-19-00
Protocol code:
ZKSJ0153
NCT ID:
NCT06134492
Trial Phase:
Therapeutic confirmatory (Phase III)

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