Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL

Launched by JENA UNIVERSITY HOSPITAL · Nov 10, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called acyclovir can help patients who are on mechanical ventilation due to pneumonia and have a high amount of herpes simplex virus (HSV) in their lungs. HSV is a common virus that many people carry, but it can cause serious infections in individuals with weakened immune systems, such as those in intensive care. The goal of the study is to determine if treating HSV with acyclovir can improve survival rates for these patients.

To be eligible for the trial, participants must be at least 18 years old, require invasive ventilation for at least 48 hours, and have a confirmed presence of HSV in their lungs. Patients will be randomly assigned to either receive acyclovir or not, allowing researchers to compare the outcomes between the two groups. This study aims to provide clearer answers about whether treating HSV is beneficial for patients with pneumonia who are critically ill. If you or a loved one are considering participation, it's important to discuss any specific health conditions or medications with the medical team to determine eligibility.

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ALL

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