Evaluation of Methods for Diagnosis of Cytomegalovirus Pneumonia in Mechanically Ventilated Patient

Viral infections are only recently been investigated in patients on mechanical ventilation (MV) in ICU. It is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. This is of course of viral infections "Community" (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. This is called viral infection "nosocomial" whose Herpesviridae are the most frequent and best studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary infection. This reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.Several studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients. For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work, however, has to date compared these techniques in the intensive care patient. In a subject shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this same study shows that half of the positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never been validated to date in intensive care. Finally, no work has so far evaluated the diagnostic performance of quantitative PCR performed on BAL

Study Overview

• Status: Unknown
• Conditions: CMV Reactivation Diagnosis in ICU Patient
• Intervention / Treatment: Biological: blood draw

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Laurent PAPAZIAN, MD/PhD; Email: laurent.papazian@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Laurent PAPAZIAN, MD/ PhD; Email: laurent.papazian@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patient undergoing invasive ventilation for more than 48h

Description

Inclusion Criteria:

• Patient in ICU with ventilator-associated pneumonia suspicion

Exclusion Criteria:

• ICU pateint undergoing invasive ventilation for less than 48 hour

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of CMV positive reactivation in ICU patient for sensitivity of quantitative PCR ( qPCR ) on LBA and CMV in whole blood compared with pp65 antigenemia.	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Laurent PAPAZIAN, MD/PhD, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 22, 2016

Study Record Updates

• Last Update Posted (Estimate): August 22, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 2012-19; 2012-A00720-43 (Other Identifier: Ansm)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO