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NCT01089400 Clinical Trial

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

Influenza Clinical Trial

— FluBAL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01089400
Other study ID # C09-39
Secondary ID
Status Completed
Phase N/A
First received March 17, 2010
Last updated January 27, 2012
Start date October 2009
Est. completion date April 2011

Study information
Verified date January 2012
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Pitie-Salpetrière Hospital Paris
France Tenon Hospital Paris

Sponsors (3)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France Assistance Publique - Hôpitaux de Paris, Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary virological parameters in nose, broncho-alveolar lavage and peripheral blood day 0 and day 5-7 of ventilation No
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