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, Randomized, Double-blinded Multicenter Trial

20126003312-30

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.

2014-02-05

2018-04-21

2023-04-05

Completed

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 317, 'type': 'ACTUAL'}}

2023-04-06