PTH - Preemptive Treatment for Herpesviridae
- Registration Number
- NCT02152358
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 317
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ganciclovir Ganciclovir Patients with a positive CMV PCR Ganciclovir placebo Placebo Patients with a positive CMV PCR Aciclovir Aciclovir Patients with a PCR positive for HSV Aciclovir placebo Placebo Patients with a positive PCR for HSV
- Primary Outcome Measures
Name Time Method Ventilator-free days at Day 60 60 days
- Secondary Outcome Measures
Name Time Method Incidence of ventilator-associated pneumonia 60 days Day 60 mortality 60 days ICU mortality 60 days Duration of mechanical ventilation in survivors 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 Hospital mortality 60 days Duration of ICU stay 60 days Duration of hospital stay 60 days Incidence of bacteremia 60 days SOFA score days 3, 5, 7, 14, 21 and 28 Acute renal failure related to aciclovir or its placebo 60 days Leucopenia related to ganciclovir or its placebo 60 days
Trial Locations
- Locations (1)
Assistance Publique - Hôpitaux de Marseille
🇫🇷Marseille, France