PTH study: Preemptive Treatment for Herpesviridae

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; mechanically ventilated patients

• Registration Number: EUCTR2012-003312-30-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-25
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Invasive mechanical ventilation for 96 hours at least and duration of predictable mechanical ventilation of at least 48 am more
- Positive PCR (see below the criteria of positivity of this PCR)
- An age of at least 18 years
- The obtaining of the written consent of the patient of one of his(her) close relations or the beforehand indicated reliable person.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 264
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 216

Exclusion Criteria

Old Patients under age 18
- Patient receiving from the ganciclovir or from the aciclovir
- Use by general way of the others antiviral active on the CMV and/or the HSV during the previous month the inclusion (cidofovir, foscarnet, to ganciclovir, yet(now) to to valacyclovir)
- Infection to CMV or to HSV treated(handled) by general way during the previous month the admission in resuscitation
- Sentimentality in the ganciclovir for the arm CMV or in the aciclovir for the arm HSV
- Pregnancy
- Feeding
- Patients hospitalized for a medullary aplasie
- Patients transplanted by solid organs or by marrow
- Expanding Patients of the HIV
- Treatment to immunosupresseur

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Patients mechanically ventilated for at least 96 hours, show that treatment with ganciclovir in patients with CMV replication by acyclovir or in those with HSV replication reduces the duration of mechanical ventilation and an improved prognosis.;Secondary Objective: Mortality to J60<br>- Mortality in resuscitation<br>- Hospitable(hospital) Mortality<br>- Lasted invasive mechanical ventilation<br>- Lasted hospitalization in resuscitation<br>- Lasted hospitalization<br>- Incidence of the active infections to CMV - Rate of reactivations<br>- Incidence of bronchopneumonies herpétiques<br>- Evolution of the failures of organs to J3, J5, J7, J14, J21 and J28 estimated by the score SOFA;Primary end point(s): Number of alive days without mechanical ventilation to J60 after the randomization.;Timepoint(s) of evaluation of this end point: 3years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mortalities to J60, in resuscitation and hospitable<br>- Lasted total of mechanical ventilation at the survivors<br>- Lasted total of stay in resuscitation and at the hospital<br>- Incidence of the bacterial pneumonias acquired under mechanical ventilation and bactériémies;Timepoint(s) of evaluation of this end point: 3 years