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

Phase 1

Recruiting

• Conditions: Patients in the intensive care unit on invasive mechanical ventilation with pneumonia and detection of herpes simplex virus type 1 (HSV-1) in bronchoalveolar lavage (BAL).; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2023-504322-19-00
• Lead Sponsor: Friedrich Schiller Universitaet Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 710

Inclusion Criteria

= 18 years, Invasive ventilation expected for = 48 hours from time of randomization, PCR HSV-1 detection in BAL (= 105 copies/ml), Pneumonia (community or healthcare acquired incl. ventilator-associated pneumonia), Written declaration of consent by the patient or legal representative.

Exclusion Criteria

History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product, Pregnancy/Lactation, Simultaneous participation in another interventional clinical trial, Decision to withhold life-sustaining therapies, Use of a virostatic agent (i.v. or p. os) with activity against herpes simplex (valacyclovir, famciclovir/penciclovir, brivudine, cidofovir, foscarnet) for therapeutic or prophylactic reasons at the time of randomization, Solid organ transplantation, stem cell transplantation, Neutropenia (absolute neutrophil count <1500/µl (<1.5 × 109 /l), Previous study participation in HerpMV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Testing the impact of the intervention on mortality (30-day mortality).;Secondary Objective: Hospital and intensive care unit length of stay, HSV-1 eradication, Organ dysfunction, Safety of intervention;Primary end point(s): 30-day mortality (Survival time)