NCT06134492 Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL
| NCT ID | NCT06134492 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jena University Hospital |
| Condition | Pneumonia, Viral |
| Study Type | INTERVENTIONAL |
| Enrollment | 616 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 616 participants in total. It began in 2024-02-20 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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. Simultaneous participation in another interventional clinical trial 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
Frequently Asked Questions
Who can join the NCT06134492 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pneumonia, Viral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06134492 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 616 participants.
Is NCT06134492 currently recruiting?
Yes, NCT06134492 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jena University Hospital to inquire about joining.
Where is the NCT06134492 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany, Heidelberg, Germany, Heidelberg, Germany, Tübingen, Germany and 11 additional locations.
Who is sponsoring the NCT06134492 clinical trial?
NCT06134492 is sponsored by Jena University Hospital. The trial plans to enroll 616 participants.