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PTH - Preemptive Treatment for Herpesviridae

Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Viral Pneumonia

Intervention: Aciclovir (Drug); Ganciclovir (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Assistance Publique Hopitaux De Marseille

Official(s) and/or principal investigator(s):
Laurent Papazian, MD, PhD, Principal Investigator, Affiliation: APHM - AMU

Overall contact:
Laurent Papazian, MD, PhD, Phone: +33491965836, Email: laurent.papazian@ap-hm.fr

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Ventilator-free days at Day 60

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Laurent Papazian, MD, PhD, Phone: +33491965836, Email: laurent.papazian@ap-hm.fr

Assistance Publique - Hôpitaux de Marseille, Marseille 13015, France; Recruiting
Laurent Papazian, MD, PhD
Laurent Papazian, MD, PhD, Principal Investigator
Additional Information

Starting date: March 2014
Last updated: August 20, 2015

Page last updated: August 23, 2015

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