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OpenTrials
Completed

NCT Number: NCT01089400

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. immunological parameters in blood and bronchoalveolar lavage fluid

    Time frame: 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

    Time frame: day 0 and day 5-7 of ventilation

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Institut Pasteur

Registry information

Official study title

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

Acronym: FluBAL

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 18, 2010
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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