NCT02152358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

4.2 years

First QC Date

March 26, 2014

Last Update Submit

April 5, 2023

Conditions

Viral Pneumonia

Keywords

CytomegalovirusHerpes simplex virusICUmechanical ventilationmortalityventilator-free daysPCR

Outcome Measures

Primary Outcomes (1)

  • Ventilator-free days at Day 60

    60 days

Secondary Outcomes (15)

  • Day 60 mortality

    60 days

  • ICU mortality

    60 days

  • Hospital mortality

    60 days

  • Duration of mechanical ventilation in survivors

    60 days

  • Duration of ICU stay

    60 days

  • +10 more secondary outcomes

Study Arms (4)

Ganciclovir

ACTIVE COMPARATOR

Patients with a positive CMV PCR

Drug: Ganciclovir

Ganciclovir placebo

PLACEBO COMPARATOR

Patients with a positive CMV PCR

Drug: Placebo

Aciclovir

ACTIVE COMPARATOR

Patients with a PCR positive for HSV

Drug: Aciclovir

Aciclovir placebo

PLACEBO COMPARATOR

Patients with a positive PCR for HSV

Drug: Placebo

Interventions

AciclovirDRUG

Intravenous 15 mg/kg/d during 14 days

Aciclovir
GanciclovirDRUG

intravenous 10 mg/kg/d for 14 days

Ganciclovir
PlaceboDRUG
Aciclovir placeboGanciclovir placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, 13015, France

Location

Related Publications (1)

  • 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.

    PMID: 31841577DERIVED

MeSH Terms

Conditions

Pneumonia, ViralHerpes Simplex

Interventions

AcyclovirGanciclovir

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract DiseasesHerpesviridae InfectionsDNA Virus InfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Laurent Papazian, MD, PhD

    APHM - AMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

June 2, 2014

Study Start

February 5, 2014

Primary Completion

April 21, 2018

Study Completion

April 5, 2023

Last Updated

April 6, 2023

Record last verified: 2023-04

Locations

FR(1)