PTH - Preemptive Treatment for Herpesviridae

Viral Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152358
• Other study ID #: 20126003312-30
• Secondary ID: 2012-003312-30
• Status: Completed
• Phase: Phase 4
• Start date: February 5, 2014
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: April 5, 2023
• Est. primary completion date: April 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia, Viral
• Viral Pneumonia

Intervention

Drug:
• Aciclovir
Intravenous 15 mg/kg/d during 14 days
• Ganciclovir
intravenous 10 mg/kg/d for 14 days
• Placebo

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free days at Day 60		60 days
Secondary	Day 60 mortality		60 days
Secondary	ICU mortality		60 days
Secondary	Hospital mortality		60 days
Secondary	Duration of mechanical ventilation in survivors		60 days
Secondary	Duration of ICU stay		60 days
Secondary	Duration of hospital stay		60 days
Secondary	Incidence of ventilator-associated pneumonia		60 days
Secondary	Incidence of bacteremia		60 days
Secondary	SOFA score		days 3, 5, 7, 14, 21 and 28
Secondary	Acute renal failure related to aciclovir or its placebo		60 days
Secondary	Leucopenia related to ganciclovir or its placebo		60 days
Secondary	Time to oropharyngeal negativation of HSV PCR		30 days
Secondary	Time to blood negativation of CMV PCR		30 days
Secondary	Incidence of herpetic bronchopneumonia		60 days
Secondary	Incidence of active CMV infection		60 days