PTH - Preemptive Treatment for Herpesviridae

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Unknown status

CT.gov ID

NCT02152358

Collaborator

(none)

480

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Viral Pneumonia	Drug: Aciclovir Drug: Ganciclovir Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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, Randomized, Double-blinded Multicenter Trial

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ganciclovir Patients with a positive CMV PCR	Drug: Ganciclovir intravenous 10 mg/kg/d for 14 days
Placebo Comparator: Ganciclovir placebo Patients with a positive CMV PCR	Drug: Placebo
Active Comparator: Aciclovir Patients with a PCR positive for HSV	Drug: Aciclovir Intravenous 15 mg/kg/d during 14 days
Placebo Comparator: Aciclovir placebo Patients with a positive PCR for HSV	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Ventilator-free days at Day 60 [60 days]

Secondary Outcome Measures

Day 60 mortality [60 days]
ICU mortality [60 days]
Hospital mortality [60 days]
Duration of mechanical ventilation in survivors [60 days]
Duration of ICU stay [60 days]
Duration of hospital stay [60 days]
Incidence of ventilator-associated pneumonia [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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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