Pneumonia, ViralPhase 3HerpMVNCT06134492
Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL
A Phase 3 study testing Acyclovir in people with Pneumonia, Viral and Ventilator Associated Pneumonia, run by Jena University Hospital at 28 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Viral, Ventilator Associated Pneumonia, Community-acquired Pneumonia
- What is being tested?
- Acyclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 28 sitesGermany
- Study dates
- 20 Feb 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product.
- 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
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
Germany28 sites, 28 recruiting
- Recruiting
Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156
Phillip Simon, Prof. Dr., 08214002378, philipp.simon3@uk-augsburg.de
Phillip Simon, Prof. Dr.
- Recruiting
Evangelisches Klinikum Bethel
Bielefeld, North Rhine-Westphalia, 33617
Friedhelm Bach, Dr., 052177279107, friedhelm.bach@evkb.de
Friedhelm Bach, Dr.
- Recruiting
Evangelisches Klinikum Bethel
Bielefeld, 33611
Friedhelm Bach, Dr., 049 521 77279107, friedhelm.bach@evkb.de
Friedhelm Bach, Dr.
- Recruiting
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Christian Putensen, Prof. Dr., 022828714119, putensen@uni-bonn.de
Christian Putensen, Prof. Dr.
- Recruiting
Universitätsklinikum Köln AöR
Cologne, North Rhine-Westphalia, 50937
Fabian Dusse, Dr., 022147842113, fabian.dusse@uk-koeln.de
Fabian Dusse, Dr.
- Recruiting
Universitätsklinikum Dresden
Dresden, Saxony, 01307
Andreas Güldner, Dr. med., 035145818493, andreas.gueldner@ukdd.de
Andreas Güldner, Dr. med.
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Christian Jung, Prof. Dr., 02118118801, christian.jung@med.uni-duesseldorf.de
Christian Jung, Prof. Dr.
- Recruiting
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Thorsten Brenner, Prof. Dr., 0201 723 1401, anaesthesiologie@uk-essen.de
Thorsten Brenner, Prof. Dr. med.
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Paul Biever, Dr., 076127034931, paul.biever@uniklinik-freiburg.de
Paul Biever, Dr.
- Recruiting
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 06120
Alexander Vogt, Dr., 03455573134, alexander.vogt@uk-halle.de
Alexander Vogt, Dr.
- Recruiting
Universitätsklinikum Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Stefan Kluge, Prof. Dr., 040741057010, s.kluge@uke.de
Stefan Kluge, Prof. Dr.
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Markus Weigand, Prof. Dr., 06221 56-36351, anae.sekretariat@med.uni-heidelberg.de
Markus Weigand, Prof. Dr.
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Tobias Gutting, Dr., 062215637985, tobias.gutting@med.uni-heidelberg.de
Tobias Gutting, Dr.
- Recruiting
Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum
Herne, Nordreihn-Westfalen, 44625
Ulrich Frey, Prof. Dr., 023234991575, ulrich.frey@elisabethgruppe.de
Ulrich Frey, Prof. Dr. med.
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
Frank Bloos, PD Dr., 036419323283, frank.bloos@med.uni-jena.de
- Recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105
Matthias Lindner, Dr., 043150068103, Matthias.Lindner@uksh.de
Matthias Lindner, Dr.
- Recruiting
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Sirak Petros, Prof. Dr., 03419712700, MB-Internistische-Intensivmedizin@medizin.uni-leipzig.de
Sirak Petros, Prof. Dr.
- Recruiting
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Gunther Hempel, Dr., 03419717136, studien-kai@medizin.uni-leipzig.de
Gunther Hempel, Dr.
- Recruiting
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
Maria Deja, Prof. Dr., 045150040710, maria.deja@uksh.de
Maria Deja, Prof. Dr.
- Recruiting
Klinikum der Ludwig-Maximilian-Universität München
München, Bavaria, 81377
Michael Zoller, Dr., 015254849023, michael.zoller@med.uni-muenchen.de
Michael Zoller, Dr.
- Recruiting
Klinikum rechts der Isar
München, Bavaria, 81675
Markus Heim, Dr., 08941405990, m.heim@tum.de
Markus Heim, Dr.
- Recruiting
Klinikum rechts der Isar
München, Bavaria, 81675
Tobias Lahmer, Dr., 08941409345, tobias.lahmer@mri.tum.de
Tobias Lahmer, Dr.
- Recruiting
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Christian Ertmer, Prof. Dr., 02518348735, ertmer@anit.uni-muenster.de
Christian Ertmer, Prof. Dr.
- Recruiting
Klinikum Nürnberg, Campus Nord
Nuremberg, Bavaria, 90419
Arnim Geise, Dr., 09113983479, arnim.geise@klinikum-nuernberg.de
Arnim Geise, Dr.
- Recruiting
Klinikum Nürnberg, Campus Süd
Nuremberg, Bavaria, 90471
Silke Fortenbacher, Dr., 0911398118734, silke.fortenbacher@klinikum-nuernberg.de
Silke Fortenbacher, Dr.
- Recruiting
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053
Alexander Dejaco, Dr., 09419447801, alexander.dejaco@klinik.uni-regensburg.de
Alexander Dejaco, Dr.
- Recruiting
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, 83022
Balázs Poros, Dr., 080313656841, balzs.poros@ro-med.de
Balázs Poros, Dr.
- Recruiting
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Peter Rosenberger, Prof. Dr., 070712986622, peter.rosenberger@med.uni-tuebingen.de
Peter Rosenberger, Prof. Dr.
About this study
Official title: Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage
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.
Read the detailed description
Herpes-simplex virus (HSV) can be detected in the bronchoalveolar lavage (BAL) in up to 60% of mechanically ventilated (MV) ICU patients with a lower respiratory tract infection (LRTI), depending on the study population and the severity of disease. However, it remains unclear whether the detection represents a harmless viral shedding as a consequence of reactivation, reflecting the severity of the underlying disease and immunoparalysis, or a true clinical infection requiring antiviral therapy. To date, only retrospective studies have investigated the benefit of an antiviral therapy in HSV-positive ICU patients on mechanical ventilation (MV) with LRTI. In a retrospective study and additional meta-analysis on this topic a antiviral treatment was associated with an improved patient outcome, i.e.; lower all-cause hospital mortality (RR 0.74, 95% CI 0.64-0.85) and lower 30-day all-cause mortality (RR 0.75, 95% CI 0.59-0.94; 3 studies). Aim of this study is to determine prospectively in a multicenter, randomized controlled trial whether acyclovir therapy improves outcome in ventilated ICU patients with a LRTI and HSV detection in BAL. Overall, 616 ICU patients with MV and LRTI and HSV1-PCR-detection in BAL (>= 10E3 copies/ml) will be either randomized to receive acyclovir (10mg/kg body weight tid) for 10 days (or discharge from ICU if this is earlier) or no antiviral therapy (control group). Primary efficacy endpoint will be overall survival within 30 days comparing the acyclovir therapy and the control group. Secondary endpoints include ventilation-free days up to day 30, vasopressor-free days until day 30 and safety.
- Conditions
- Pneumonia, Viral, Ventilator Associated Pneumonia, Community-acquired Pneumonia, Herpes Simplex, Hospital-acquired Pneumonia
- Being tested
- Acyclovir
- Keywords
- Pneumonia, Herpes Simplex, Mechanical Ventilation, Aciclovir
- Medical subject headings
- Pneumonia, Viral, Pneumonia, Ventilator-Associated, Community-Acquired Pneumonia, Herpes Simplex, Healthcare-Associated Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Also called Aciclovir
Dosage: 10mg/kg (current) body weight every 8 hours, dose adjustment to renal function according to technical information.
Mode of administration: intravenous (i.v.)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Aciclovir therapy Receives: Drug: Acyclovir |
| Comparison group | No intervention | No study-specific treatment measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality (survival status)
survival status
Measured: day 30
Secondary outcomes (14)
Ventilation-free days
days without mechanically ventilation via endotracheal tube, incl. tracheostoma
Measured: day 30
Vasopressor-free days
days without continuous vasopressor administration > 1h/day
Measured: day 30
Delta SOFA score (Sepsis-related Organ Failure Assessment Score)
Each of six organ systems receive a score ranging from 0 (normal) to 4 (most abnormal), with a minimum SOFA score of 0 and a maximum SOFA score of 24
Measured: Baseline - Day 10 or EOT if this event occurs earlier
Delta SOFA sub-score kidney (Sepsis-related Organ Failure Assessment Score)
Sub-score for kidney function, the score ranges from 0 (normal) to 4 (most abnormal)
Measured: Baseline - Day 10 or EOT if this event occurs earlier
Delta GFR value
GFR value
Measured: Baseline - Day 10 or EOT if this event occurs earlier
Length of stay in ICU
days LOS in ICU
Measured: day 30
Length of stay in Hospital
days LOS in hospital
Measured: day 30
Cost of intervention
ICU and hospitalization days + acyclovir
Measured: up to day 90
Days without delirium/coma
based on CAM-ICU / RASS
Measured: Until day 10 or until EOT if this event occurs earlier
Microbiological cure (EOT)
Percent of participants with HSV eradication (PCR testing negative) in blood and respiratory tract
Measured: At day 10 or day of EOT if this event occurs earlier
mortality (survival status)
survival status
Measured: 90 days
mortality (survival status)
survival status
Measured: 180 days
Quality of life (EQ-5D-5L)
EuroQuality of Life Five Dimensions (EQ-5D-5L), the descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), with five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems.
Measured: Measurement at day 10 or EOT if this event occurs earlier, day 30, day 90, and day 180
Incidence SAEs
Incidence of serious adverse events
Measured: From time of randomization until day 10 or EOT if this event occurs earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Feb 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Hagel, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134492
- Sponsor's protocol ID
- ZKSJ0153
- Other IDs
- BMBF 01KG2301
- Acronym
- HerpMV
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published in a journal indexed in MEDLINE and CTIS; there are no publication restrictions. After publication, deidentified, individual participant data that underlie this trial, along with a data dictionary describing variables in the dataset, will be made available to researchers whose proposed purpose of use is approved by the Trial Management Team.
Publications
Hagel S, Brillinger N, Decker S, Deja M, Ertmer C, Fiedler S, Franken P, Heim M, Weigand MA, Zarbock A, Pletz MW; SepNet Critical Care Trials Group. 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). BMJ Open. 2024 Apr 25;14(4):e082512. doi: 10.1136/bmjopen-2023-082512.
PubMed 38670599
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage
- ClinicalTrials.gov ID
- NCT06134492
- Acronym / sponsor ID
- HerpMV / ZKSJ0153
- Conditions
- Pneumonia, Viral, Ventilator Associated Pneumonia, Community-acquired Pneumonia, Herpes Simplex, Hospital-acquired Pneumonia
- Keywords
- Pneumonia, Herpes Simplex, Mechanical Ventilation, Aciclovir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Herpes-simplex virus (HSV) can be detected in the bronchoalveolar lavage (BAL) in up to 60% of mechanically ventilated (MV) ICU patients with a lower respiratory tract infection (LRTI), depending on the study population and the severity of disease. However, it remains unclear whether the detection represents a harmless viral shedding as a consequence of reactivation, reflecting the severity of the underlying disease and immunoparalysis, or a true clinical infection requiring antiviral therapy. To date, only retrospective studies have investigated the benefit of an antiviral therapy in HSV-positive ICU patients on mechanical ventilation (MV) with LRTI. In a retrospective study and additional meta-analysis on this topic a antiviral treatment was associated with an improved patient outcome, i.e.; lower all-cause hospital mortality (RR 0.74, 95% CI 0.64-0.85) and lower 30-day all-cause mortality (RR 0.75, 95% CI 0.59-0.94; 3 studies). Aim of this study is to determine prospectively in a multicenter, randomized controlled trial whether acyclovir therapy improves outcome in ventilated ICU patients with a LRTI and HSV detection in BAL. Overall, 616 ICU patients with MV and LRTI and HSV1-PCR-detection in BAL (>= 10E3 copies/ml) will be either randomized to receive acyclovir (10mg/kg body weight tid) for 10 days (or discharge from ICU if this is earlier) or no antiviral therapy (control group). Primary efficacy endpoint will be overall survival within 30 days comparing the acyclovir therapy and the control group. Secondary endpoints include ventilation-free days up to day 30, vasopressor-free days until day 30 and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: AcyclovirAciclovir therapy |
| Comparison group | No intervention | –No study-specific treatment measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcyclovirAlso: AciclovirDosage: 10mg/kg (current) body weight every 8 hours, dose adjustment to renal function according to technical information. Mode of administration: intravenous (i.v.) | Drug | Treatment group |
Primary outcome
mortality (survival status)
Time frame: day 30
survival status
14 secondary outcomes
Ventilation-free days
Time frame: day 30
Vasopressor-free days
Time frame: day 30
Delta SOFA score (Sepsis-related Organ Failure Assessment Score)
Time frame: Baseline - Day 10 or EOT if this event occurs earlier
Delta SOFA sub-score kidney (Sepsis-related Organ Failure Assessment Score)
Time frame: Baseline - Day 10 or EOT if this event occurs earlier
Delta GFR value
Time frame: Baseline - Day 10 or EOT if this event occurs earlier
Length of stay in ICU
Time frame: day 30
Length of stay in Hospital
Time frame: day 30
Cost of intervention
Time frame: up to day 90
Days without delirium/coma
Time frame: Until day 10 or until EOT if this event occurs earlier
Microbiological cure (EOT)
Time frame: At day 10 or day of EOT if this event occurs earlier
mortality (survival status)
Time frame: 90 days
mortality (survival status)
Time frame: 180 days
Quality of life (EQ-5D-5L)
Time frame: Measurement at day 10 or EOT if this event occurs earlier, day 30, day 90, and day 180
Incidence SAEs
Time frame: From time of randomization until day 10 or EOT if this event occurs earlier
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 38670599Hagel S, Brillinger N, Decker S, Deja M, Ertmer C, Fiedler S, Franken P, Heim M, Weigand MA, Zarbock A, Pletz MW; SepNet Critical Care Trials Group. 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). BMJ Open. 2024 Apr 25;14(4):e082512. doi: 10.1136/bmjopen-2023-082512.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results will be published in a journal indexed in MEDLINE and CTIS; there are no publication restrictions. After publication, deidentified, individual participant data that underlie this trial, along with a data dictionary describing variables in the dataset, will be made available to researchers whose proposed purpose of use is approved by the Trial Management Team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acyclovir in people with Pneumonia, Viral and Ventilator Associated Pneumonia, run by Jena University Hospital at 28 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (survival status) (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.