Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage

Completed

• Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome; Influenza

• Registration Number: NCT01089400
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

The influenza A/H1N1v pandemic virus causes severe pneumonia that can lead to acute respiratory distress syndrome and death even in healthy young individuals. The respective roles of viral replication, bacterial infection and immune alterations of the host during such severe influenza H1N1v infection need to be clarified in order to optimize patients care. In this context, we aim to study immune and virological parameters in bronchoalveolar lavage fluid during severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit. Results will be correlated to bacterial or viral pulmonary co-infections and to peripheral blood immune and virological parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Study Completion: 2011-04
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Suspected influenza A/H1N1 infection
• Diffuse bilateral pneumonia <96h with acute lung injury or respiratory distress syndrome
• Invasive or non-invasive ventilation in intensive care unit
• Age > 13

Exclusion Criteria

• Other cause identified of acute lung injury or acute respiratory distress syndrome
• Contraindicated bronchoalveolar lavage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
immunological parameters in blood and bronchoalveolar lavage fluid	day 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood

Secondary Outcome Measures

Name	Time	Method
virological parameters in nose, broncho-alveolar lavage and peripheral blood	day 0 and day 5-7 of ventilation

Trial Locations

Locations (2)

Tenon Hospital; 🇫🇷 Paris, France

Pitie-Salpetrière Hospital; 🇫🇷 Paris, France