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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01089400
Acronym
FluBAL
Enrollment
30
Registered
2010-03-18
Start date
2009-10-31
Completion date
2011-04-30
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Acute Respiratory Distress Syndrome, Influenza

Keywords

influenza, H1N1, lymphocytes, T cell, CD4, CD8, cytokine, serology, broncho-alveolar lavage, acute respiratory distress syndrome, ventilation, 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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Institut Pasteur
CollaboratorINDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
immunological parameters in blood and bronchoalveolar lavage fluidday 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood

Secondary

MeasureTime frame
virological parameters in nose, broncho-alveolar lavage and peripheral bloodday 0 and day 5-7 of ventilation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026