PTH - Preemptive Treatment for Herpesviridae

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Completed; Phase 4

Conditions: Viral Pneumonia

Treatments: Drug: Placebo; Drug: Ganciclovir; Drug: Aciclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT02152358

20126003312-30

2012-003312-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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317 participants in 4 patient groups, including a placebo group

Ganciclovir

Active Comparator group

Description:

Patients with a positive CMV PCR

Treatment:

Drug: Ganciclovir

Ganciclovir placebo

Placebo Comparator group

Description:

Patients with a positive CMV PCR

Treatment:

Drug: Placebo

Aciclovir

Active Comparator group

Description:

Patients with a PCR positive for HSV

Treatment:

Drug: Aciclovir

Aciclovir placebo

Placebo Comparator group

Description:

Patients with a positive PCR for HSV

Treatment:

Drug: Placebo