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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Completed

CT.gov ID

NCT01089400

Collaborator

Assistance Publique - Hôpitaux de Paris (Other), Institut Pasteur (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza Acute Lung Injury Acute Respiratory Distress Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage in Patients Requiring Mechanical Ventilation in Intensive Care Unit

Study Start Date :

Oct 1, 2009

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Influenza A/H1N1 patients
Non influenza A/H1N1 patients

Outcome Measures

Primary Outcome Measures

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

virological parameters in nose, broncho-alveolar lavage and peripheral blood [day 0 and day 5-7 of ventilation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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