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PTH - Preemptive Treatment for Herpesviridae (PTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02152358
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : July 2, 2019
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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 identifier (NCT number): NCT02152358

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Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13015
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Principal Investigator: Laurent Papazian, MD, PhD APHM - AMU
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT02152358    
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:
Herpes simplex virus
mechanical ventilation
ventilator-free days
Additional relevant MeSH terms:
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Pneumonia, Viral
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action