A Phase 3 interventional study of Acyclovir in Pneumonia, Viral, Ventilator Associated Pneumonia and Community-acquired Pneumonia, sponsored by Jena University Hospital. Recruiting at 28 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Jena University Hospital · Phase 3, Interventional, and Treatment
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.
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.
156 studies on the registry are indexed under Pneumonia, Viral; 13 are open to participants now.
This study's planned enrollment of 616 is above the median of 76 across 88 interventional studies indexed under Pneumonia, Viral.
Browse Pneumonia, Viral studies →Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 ( \<1500/μl (\<1.5 × 109 /l) 8.Previous study participation in HerpMV
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aciclovir therapy
Drug: Acyclovir
No study-specific treatment measures
Dosage: 10mg/kg (current) body weight every 8 hours, dose adjustment to renal function according to technical information. Mode of administration: intravenous (i.v.)
Also known as: Aciclovir
mortality (survival status)
survival status
Time frame: day 30
Ventilation-free days
days without mechanically ventilation via endotracheal tube, incl. tracheostoma
Time frame: day 30
Vasopressor-free days
days without continuous vasopressor administration \> 1h/day
Time frame: 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
Time frame: 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)
Time frame: Baseline - Day 10 or EOT if this event occurs earlier
Delta GFR value
GFR value
Time frame: Baseline - Day 10 or EOT if this event occurs earlier
Length of stay in ICU
days LOS in ICU
Time frame: day 30
Length of stay in Hospital
days LOS in hospital
Time frame: day 30
Cost of intervention
ICU and hospitalization days + acyclovir
Time frame: up to day 90
Days without delirium/coma
based on CAM-ICU / RASS
Time frame: 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
Time frame: At day 10 or day of EOT if this event occurs earlier
mortality (survival status)
survival status
Time frame: 90 days
mortality (survival status)
survival status
Time frame: 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.
Time frame: 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
Time frame: From time of randomization until day 10 or EOT if this event occurs earlier
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After publication
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Studies of the drug tested here: Acyclovir
Jena University Hospital