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PTH - Preemptive Treatment for Herpesviridae (PTH)

Primary Purpose

Viral Pneumonia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Aciclovir
Ganciclovir
Placebo
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Pneumonia focused on measuring Cytomegalovirus, Herpes simplex virus, ICU, mechanical ventilation, mortality, ventilator-free days, PCR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique - Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Ganciclovir

Ganciclovir placebo

Aciclovir

Aciclovir placebo

Arm Description

Patients with a positive CMV PCR

Patients with a positive CMV PCR

Patients with a PCR positive for HSV

Patients with a positive PCR for HSV

Outcomes

Primary Outcome Measures

Ventilator-free days at Day 60

Secondary Outcome Measures

Day 60 mortality
ICU mortality
Hospital mortality
Duration of mechanical ventilation in survivors
Duration of ICU stay
Duration of hospital stay
Incidence of ventilator-associated pneumonia
Incidence of bacteremia
SOFA score
Acute renal failure related to aciclovir or its placebo
Leucopenia related to ganciclovir or its placebo
Time to oropharyngeal negativation of HSV PCR
Time to blood negativation of CMV PCR
Incidence of herpetic bronchopneumonia
Incidence of active CMV infection

Full Information

First Posted
March 26, 2014
Last Updated
April 5, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02152358
Brief Title
PTH - Preemptive Treatment for Herpesviridae
Acronym
PTH
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2014 (Actual)
Primary Completion Date
April 21, 2018 (Actual)
Study Completion Date
April 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Pneumonia
Keywords
Cytomegalovirus, Herpes simplex virus, ICU, mechanical ventilation, mortality, ventilator-free days, PCR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ganciclovir
Arm Type
Active Comparator
Arm Description
Patients with a positive CMV PCR
Arm Title
Ganciclovir placebo
Arm Type
Placebo Comparator
Arm Description
Patients with a positive CMV PCR
Arm Title
Aciclovir
Arm Type
Active Comparator
Arm Description
Patients with a PCR positive for HSV
Arm Title
Aciclovir placebo
Arm Type
Placebo Comparator
Arm Description
Patients with a positive PCR for HSV
Intervention Type
Drug
Intervention Name(s)
Aciclovir
Intervention Description
Intravenous 15 mg/kg/d during 14 days
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Intervention Description
intravenous 10 mg/kg/d for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Ventilator-free days at Day 60
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Day 60 mortality
Time Frame
60 days
Title
ICU mortality
Time Frame
60 days
Title
Hospital mortality
Time Frame
60 days
Title
Duration of mechanical ventilation in survivors
Time Frame
60 days
Title
Duration of ICU stay
Time Frame
60 days
Title
Duration of hospital stay
Time Frame
60 days
Title
Incidence of ventilator-associated pneumonia
Time Frame
60 days
Title
Incidence of bacteremia
Time Frame
60 days
Title
SOFA score
Time Frame
days 3, 5, 7, 14, 21 and 28
Title
Acute renal failure related to aciclovir or its placebo
Time Frame
60 days
Title
Leucopenia related to ganciclovir or its placebo
Time Frame
60 days
Title
Time to oropharyngeal negativation of HSV PCR
Time Frame
30 days
Title
Time to blood negativation of CMV PCR
Time Frame
30 days
Title
Incidence of herpetic bronchopneumonia
Time Frame
60 days
Title
Incidence of active CMV infection
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Papazian, MD, PhD
Organizational Affiliation
APHM - AMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31841577
Citation
Luyt CE, Forel JM, Hajage D, Jaber S, Cayot-Constantin S, Rimmele T, Coupez E, Lu Q, Diallo MH, Penot-Ragon C, Clavel M, Schwebel C, Timsit JF, Bedos JP, Hauw-Berlemont C, Bourenne J, Mayaux J, Lefrant JY, Mira JP, Combes A, Wolff M, Chastre J, Papazian L; Preemptive Treatment for Herpesviridae Study Group, Reseau Europeen de recherche en Ventilation Artificielle Network. Acyclovir for Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):263-272. doi: 10.1001/jamainternmed.2019.5713.
Results Reference
derived

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PTH - Preemptive Treatment for Herpesviridae

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