Clinical Trial: PTH - Preemptive Treatment for Herpesviridae
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomiz
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 Summary:
Sponsor: Assistance Publique Hopitaux De Marseille
Current Primary Outcome: Ventilator-free days at Day 60 [ Time Frame: 60 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Day 60 mortality [ Time Frame: 60 days ]
- ICU mortality [ Time Frame: 60 days ]
- Hospital mortality [ Time Frame: 60 days ]
- Duration of mechanical ventilation in survivors [ Time Frame: 60 days ]
- Duration of ICU stay [ Time Frame: 60 days ]
- Duration of hospital stay [ Time Frame: 60 days ]
- Incidence of ventilator-associated pneumonia [ Time Frame: 60 days ]
- Incidence of bacteremia [ Time Frame: 60 days ]
- SOFA score [ Time Frame: days 3, 5, 7, 14, 21 and 28 ]
- Acute renal failure related to aciclovir or its placebo [ Time Frame: 60 days ]
- Leucopenia related to ganciclovir or its placebo [ Time Frame: 60 days ]
- Time to oropharyngeal negativation of HSV PCR [ Time Frame: 30 days ]
- Time to blood negativation of CMV PCR [ Time Frame: 30 days ]
- Incidence of herpetic bronchopneumonia [ Time Frame: 60 days ]
- Incidence of active CMV infection [ Time Frame: 60 days ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique Hopitaux De Marseille
Dates:
Date Received: March 26, 2014
Date Started: March 2014
Date Completion: July 2018
Last Updated: August 20, 2015
Last Verified: August 2015