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Completed

NCT Number: NCT02152358

PTH - Preemptive Treatment for Herpesviridae

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.

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Key information

Conditions

Viral Pneumonia DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Lung Diseases Pneumonia Pneumonia, Viral Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assistance Publique - Hôpitaux de Marseille

Marseille, 13015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aciclovir

Drug

Intravenous 15 mg/kg/d during 14 days

Ganciclovir

Drug

intravenous 10 mg/kg/d for 14 days

Placebo

Drug

Primary outcomes

  1. Ventilator-free days at Day 60

    Time frame: 60 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Acronym: PTH

Important dates

Study start
2014
Primary completion
2018
Study completion
2023
First posted
Jun 2, 2014
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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