PTH - Preemptive Treatment for Herpesviridae

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique Hopitaux De Marseille
• Treatments: Acyclovir; Ganciclovir; Ganciclovir triphosphate

Criteria

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