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

This study has been completed.
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
Institut Pasteur
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01089400
First received: March 17, 2010
Last updated: January 27, 2012
Last verified: January 2012
History of Changes

March 17, 2010
January 27, 2012
October 2009
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01089400 on ClinicalTrials.gov Archive Site
virological parameters in nose, broncho-alveolar lavage and peripheral blood [ Time Frame: day 0 and day 5-7 of ventilation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Bronchoalveolar lavage fuid Nasal sample Peripheral mononuclear blood cells Plasma Serum
Non-Probability Sample

Patients with severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit
  • Influenza
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
Not Provided
  • Influenza A/H1N1 patients
  • Non influenza A/H1N1 patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2011
Not Provided

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01089400
C09-39
No
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
  • Assistance Publique - Hôpitaux de Paris
  • Institut Pasteur
Principal Investigator: Amelie Guihot, MD PhD INSERM UMR945
Institut National de la Santé Et de la Recherche Médicale, France
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP