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Clinical Trials/NCT02152358
NCT02152358CompletedPhase 4

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

Assistance Publique Hopitaux De Marseille1 site in 1 country317 target enrollmentStarted: February 5, 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
317
Locations
1
Primary Endpoint
Ventilator-free days at Day 60
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Ganciclovir

Active Comparator

Patients with a positive CMV PCR

Intervention: Ganciclovir (Drug)

Ganciclovir placebo

Placebo Comparator

Patients with a positive CMV PCR

Intervention: Placebo (Drug)

Aciclovir

Active Comparator

Patients with a PCR positive for HSV

Intervention: Aciclovir (Drug)

Aciclovir placebo

Placebo Comparator

Patients with a positive PCR for HSV

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Ventilator-free days at Day 60

Time Frame: 60 days

Secondary Outcomes

  • Acute renal failure related to aciclovir or its placebo(60 days)
  • Incidence of ventilator-associated pneumonia(60 days)
  • Duration of hospital stay(60 days)
  • Day 60 mortality(60 days)
  • ICU mortality(60 days)
  • Duration of mechanical ventilation in survivors(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)
  • Hospital mortality(60 days)
  • Duration of ICU stay(60 days)
  • Incidence of bacteremia(60 days)
  • SOFA score(days 3, 5, 7, 14, 21 and 28)
  • Leucopenia related to ganciclovir or its placebo(60 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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