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Could a cold sore virus treatment save ICU pneumonia patients?

NCT ID NCT06134492

Disease control Sponsor: Jena University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests whether the antiviral drug acyclovir helps people on breathing machines who have pneumonia and also have herpes simplex virus (HSV) in their lungs. About 616 adults in intensive care will be randomly assigned to receive acyclovir or no antiviral treatment. The goal is to see if treating the virus improves survival, since current evidence is unclear and acyclovir can cause kidney side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 616 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥ 18 years 2. need for invasive or non-invasive respiratory support 3. PCR HSV-1 detection in BAL (≥ 10\^3 copies/ml) 4. Pneumonia (community or healthcare acquired, incl. ventilator-associated pneumonia) 5. declaration of consent by the patient or legal representative Exclusion Criteria: 1. History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product. 2. Pregnancy/Lactation 3.3. Simultaneous participation in another clinical interventional trial under EU Regulation 536/2014, the German Medicines Act (AMG), Medical Devices Regulation (MDR), or Medical Devices Act (MPDG) without prior consultation and approval by the respective sponsors prior to randomization 4.Decision to withhold life-sustaining therapies 5.Use of a virostatic agent (i.v. or p. os) with activity against herpes simplex (acyclovir, valacyclovir, famciclovir/penciclovir, brivudine, cidofovir, foscarnet) for therapeutic or prophylactic reasons at the time of randomization. 6.Solid organ transplantation, stem cell transplantation 7.Neutropenia (absolute neutrophil count \<1500/μl (\<1.5 × 109 /l) 8.Previous study participation in HerpMV

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia Healthcare-Associated Pneumonia herpes simplex infectious disease nosocomial infection pneumonia Pneumonia, Ventilator-Associated viral pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Community-acquired pneumonia Herpes simplex Hospital-acquired pneumonia Pneumonia, viral Ventilator associated pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Evangelisches Klinikum Bethel

    RECRUITING

    Bielefeld, North Rhine-Westphalia, 33617, Germany

  • Evangelisches Klinikum Bethel

    RECRUITING

    Bielefeld, 33611, Germany

  • Klinikum Nürnberg, Campus Nord

    RECRUITING

    Nuremberg, Bavaria, 90419, Germany

  • Klinikum Nürnberg, Campus Süd

    RECRUITING

    Nuremberg, Bavaria, 90471, Germany

  • Klinikum der Ludwig-Maximilian-Universität München

    RECRUITING

    München, Bavaria, 81377, Germany

  • Klinikum rechts der Isar

    RECRUITING

    München, Bavaria, 81675, Germany

  • Klinikum rechts der Isar

    RECRUITING

    München, Bavaria, 81675, Germany

  • Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum

    RECRUITING

    Herne, Nordreihn-Westfalen, 44625, Germany

  • RoMed Klinikum Rosenheim

    RECRUITING

    Rosenheim, Bavaria, 83022, Germany

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Freiburg

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitätsklinikum Halle

    RECRUITING

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitätsklinikum Hamburg Eppendorf

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitätsklinikum Jena

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Universitätsklinikum Köln AöR

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Münster

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitätsklinikum Regensburg

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.