Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage
FluBAL
1 other identifier
observational
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedDecember 4, 2025
January 1, 2012
1.5 years
March 17, 2010
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
virological parameters in nose, broncho-alveolar lavage and peripheral blood
day 0 and day 5-7 of ventilation
Study Arms (2)
Influenza A/H1N1 patients
Non influenza A/H1N1 patients
Eligibility Criteria
Patients with severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit
You may qualify if:
- 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
You may not qualify if:
- Other cause identified of acute lung injury or acute respiratory distress syndrome
- Contraindicated bronchoalveolar lavage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pitie-Salpetrière Hospital
Paris, France
Tenon Hospital
Paris, France
Related Publications (1)
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.
PMID: 24646009RESULT
Biospecimen
Bronchoalveolar lavage fuid Nasal sample Peripheral mononuclear blood cells Plasma Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amelie Guihot, MD PhD
INSERM UMR945
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 18, 2010
Study Start
October 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
December 4, 2025
Record last verified: 2012-01