Viral Pneumonia
Conditions
Keywords
Cytomegalovirus, Herpes simplex virus, ICU, mechanical ventilation, mortality, ventilator-free days, PCR
Brief summary
The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.
Interventions
DRUGAciclovir
Intravenous 15 mg/kg/d during 14 days
DRUGGanciclovir
intravenous 10 mg/kg/d for 14 days
DRUGPlacebo
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mechanical ventilation \> 96 hrs and expected duration of mechanical ventilation of at least 2 days * positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR * age \> 18 years * informed consent * negative pregnancy test
Exclusion criteria
* \< 18 years * Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV * Had received antiviral agent active against HSV/CMV during the previous month * Hypersensitivity to aciclovir/ganciclovir * Pregnancy * Breast feeding * Bone marrow failure * Solid organ recipients * Bone marrow recipients * HIV positive patients * Receiving immunosuppressive agents * SAPS II \> 75 * Withdrawing/withholding * Neutropenia (\< 500 mm3) * Thrombocytopenia (\< 25 G/L) * ICU readmission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator-free days at Day 60 | 60 days |
Secondary
| Measure | Time frame |
|---|---|
| ICU mortality | 60 days |
| Hospital mortality | 60 days |
| Duration of mechanical ventilation in survivors | 60 days |
| Duration of ICU stay | 60 days |
| Duration of hospital stay | 60 days |
| Incidence of ventilator-associated pneumonia | 60 days |
| Incidence of bacteremia | 60 days |
| Day 60 mortality | 60 days |
| Acute renal failure related to aciclovir or its placebo | 60 days |
| Leucopenia related to ganciclovir or its placebo | 60 days |
| Time to oropharyngeal negativation of HSV PCR | 30 days |
| Time to blood negativation of CMV PCR | 30 days |
| Incidence of herpetic bronchopneumonia | 60 days |
| Incidence of active CMV infection | 60 days |
| SOFA score | days 3, 5, 7, 14, 21 and 28 |
Countries
France
Outcome results
None listed