Effect of acyclovir therapy on the outcome of ventilated patients with lower respiratory tract infection and detection of herpes simplex virus in bronchoalveolar lavage

Conditions

Patients in the intensive care unit on ventilation with pneumonia and detection of herpes simplex virus type 1 (HSV-1) in bronchoalveolar lavage (BAL).

Brief summary

30-day mortality (Survival time)

Detailed description

Ventilation-free days up to day 30 (days without invasive ventilation via endotracheal tube, incl. tracheostoma), Vasopressor-free days until day 30 (days without continuous vasopressor administration > 1h/day), Delta SOFA (Baseline - Day 10 or EOT), Delta SOFA sub-score kidney (baseline - day 10 or EOT), Delta GFR value (baseline - day 10 or EOT), Length of stay in ICU until day 30, Length of stay in Hospital until day 30, Cost of intervention (ICU and hospitalization days + acyclovir), Days without delirium/coma (based on CAM-ICU / RASS) until day 10/end of therapy, Microbiological cure (EOT) - HSV eradication for blood and respiratory tract respectively (no HSV detectable in PCR test at end of therapy), 90 days mortality, 180 days mortality, Quality of life (EQ5D-5L) day 10 or EOT, day 30, day 90, and day 180., Incidence SAEs

Stefan Hagel, Nicole Brillinger, Sebastian Decker, Maria Deja, Christian Ertmer et al. (11 authors)

BMJ Open2024-04-012 citations

10.1136/bmjopen-2023-082512

Interventions

DRUGACICLOVIR

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
30-day mortality (Survival time)	—

Secondary

Measure	Time frame
Ventilation-free days up to day 30 (days without invasive ventilation via endotracheal tube, incl. tracheostoma), Vasopressor-free days until day 30 (days without continuous vasopressor administration > 1h/day), Delta SOFA (Baseline - Day 10 or EOT), Delta SOFA sub-score kidney (baseline - day 10 or EOT), Delta GFR value (baseline - day 10 or EOT), Length of stay in ICU until day 30, Length of stay in Hospital until day 30, Cost of intervention (ICU and hospitalization days + acyclovir), Days without delirium/coma (based on CAM-ICU / RASS) until day 10/end of therapy, Microbiological cure (EOT) - HSV eradication for blood and respiratory tract respectively (no HSV detectable in PCR test at end of therapy), 90 days mortality, 180 days mortality, Quality of life (EQ5D-5L) day 10 or EOT, day 30, day 90, and day 180., Incidence SAEs	—

Measure

Time frame

Ventilation-free days up to day 30 (days without invasive ventilation via endotracheal tube, incl. tracheostoma), Vasopressor-free days until day 30 (days without continuous vasopressor administration > 1h/day), Delta SOFA (Baseline - Day 10 or EOT), Delta SOFA sub-score kidney (baseline - day 10 or EOT), Delta GFR value (baseline - day 10 or EOT), Length of stay in ICU until day 30, Length of stay in Hospital until day 30, Cost of intervention (ICU and hospitalization days + acyclovir), Days without delirium/coma (based on CAM-ICU / RASS) until day 10/end of therapy, Microbiological cure (EOT) - HSV eradication for blood and respiratory tract respectively (no HSV detectable in PCR test at end of therapy), 90 days mortality, 180 days mortality, Quality of life (EQ5D-5L) day 10 or EOT, day 30, day 90, and day 180., Incidence SAEs

—

Countries

Germany

Outcome results

None listed