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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

Tracking Information
First Submitted Date  ICMJE March 26, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date July 2, 2019
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Ventilator-free days at Day 60 [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02152358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Day 60 mortality [ Time Frame: 60 days ]
  • ICU mortality [ Time Frame: 60 days ]
  • Hospital mortality [ Time Frame: 60 days ]
  • Duration of mechanical ventilation in survivors [ Time Frame: 60 days ]
  • Duration of ICU stay [ Time Frame: 60 days ]
  • Duration of hospital stay [ Time Frame: 60 days ]
  • Incidence of ventilator-associated pneumonia [ Time Frame: 60 days ]
  • Incidence of bacteremia [ Time Frame: 60 days ]
  • SOFA score [ Time Frame: days 3, 5, 7, 14, 21 and 28 ]
  • Acute renal failure related to aciclovir or its placebo [ Time Frame: 60 days ]
  • Leucopenia related to ganciclovir or its placebo [ Time Frame: 60 days ]
  • Time to oropharyngeal negativation of HSV PCR [ Time Frame: 30 days ]
  • Time to blood negativation of CMV PCR [ Time Frame: 30 days ]
  • Incidence of herpetic bronchopneumonia [ Time Frame: 60 days ]
  • Incidence of active CMV infection [ Time Frame: 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PTH - Preemptive Treatment for Herpesviridae
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Viral Pneumonia
Intervention  ICMJE
  • Drug: Aciclovir
    Intravenous 15 mg/kg/d during 14 days
  • Drug: Ganciclovir
    intravenous 10 mg/kg/d for 14 days
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Ganciclovir
    Patients with a positive CMV PCR
    Intervention: Drug: Ganciclovir
  • Placebo Comparator: Ganciclovir placebo
    Patients with a positive CMV PCR
    Intervention: Drug: Placebo
  • Active Comparator: Aciclovir
    Patients with a PCR positive for HSV
    Intervention: Drug: Aciclovir
  • Placebo Comparator: Aciclovir placebo
    Patients with a positive PCR for HSV
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152358
Other Study ID Numbers  ICMJE 20126003312-30
2012-003312-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laurent Papazian, MD, PhD APHM - AMU
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP