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PTH - Preemptive Treatment for Herpesviridae (PTH)

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ClinicalTrials.gov Identifier: NCT02152358
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Ventilator-free days at Day 60 [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Day 60 mortality [ Time Frame: 60 days ]
  2. ICU mortality [ Time Frame: 60 days ]
  3. Hospital mortality [ Time Frame: 60 days ]
  4. Duration of mechanical ventilation in survivors [ Time Frame: 60 days ]
  5. Duration of ICU stay [ Time Frame: 60 days ]
  6. Duration of hospital stay [ Time Frame: 60 days ]
  7. Incidence of ventilator-associated pneumonia [ Time Frame: 60 days ]
  8. Incidence of bacteremia [ Time Frame: 60 days ]
  9. SOFA score [ Time Frame: days 3, 5, 7, 14, 21 and 28 ]
  10. Acute renal failure related to aciclovir or its placebo [ Time Frame: 60 days ]
  11. Leucopenia related to ganciclovir or its placebo [ Time Frame: 60 days ]
  12. Time to oropharyngeal negativation of HSV PCR [ Time Frame: 30 days ]
  13. Time to blood negativation of CMV PCR [ Time Frame: 30 days ]
  14. Incidence of herpetic bronchopneumonia [ Time Frame: 60 days ]
  15. Incidence of active CMV infection [ Time Frame: 60 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152358


Locations
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France
Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13015
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Laurent Papazian, MD, PhD APHM - AMU

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02152358     History of Changes
Other Study ID Numbers: 20126003312-30
2012-003312-30 ( EudraCT Number )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Keywords provided by Assistance Publique Hopitaux De Marseille:
Cytomegalovirus
Herpes simplex virus
ICU
mechanical ventilation
mortality
ventilator-free days
PCR
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Ganciclovir
Acyclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action