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

NCT ID: NCT01089400

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-04-30

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.

Conditions

Influenza; Acute Lung Injury; Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Influenza A/H1N1 patients

No interventions assigned to this group

Non influenza A/H1N1 patients

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Institut Pasteur

INDUSTRY

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amelie Guihot, MD PhD

Role: PRINCIPAL_INVESTIGATOR

INSERM UMR945

Locations

Pitie-Salpetrière Hospital

Paris, , France

Tenon Hospital

Paris, , France

Countries

France

References

Guihot A, Luyt CE, Parrot A, Rousset D, Cavaillon JM, Boutolleau D, Fitting C, Pajanirassa P, Mallet A, Fartoukh M, Agut H, Musset L, Zoorob R, Kirilovksy A, Combadiere B, van der Werf S, Autran B, Carcelain G; FluBAL Study Group. Low titers of serum antibodies inhibiting hemagglutination predict fatal fulminant influenza A(H1N1) 2009 infection. Am J Respir Crit Care Med. 2014 May 15;189(10):1240-9. doi: 10.1164/rccm.201311-2071OC.

Reference Type: RESULT

PMID: 24646009 (View on PubMed)

Other Identifiers

C09-39

Identifier Type: -

Identifier Source: org_study_id