Clinical trial NCT01089400: Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage
Official title: Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage in Patients Requiring Mechanical Ventilation in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Acute Lung Injury
Acute Respiratory Distress Syndrome
Keywords: influenza
H1N1
lymphocytes
T cell
CD4
CD8
cytokine
serology
broncho-alveolar lavage
acute respiratory distress syndrome
ventilation
intensive care unit
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Institut Pasteur
First posted: 2010-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit

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.


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

Primary outcomes:
measure: immunological parameters in blood and bronchoalveolar lavage fluid
timeFrame: day 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood
Secondary outcomes:
measure: virological parameters in nose, broncho-alveolar lavage and peripheral blood
timeFrame: day 0 and day 5-7 of ventilation
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitie-Salpetrière Hospital
city: Paris
country: France
facility: Tenon Hospital
Study officials:
affiliation: INSERM UMR945
name: Amelie Guihot, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.