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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
  Purpose

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.


Condition
Influenza
Acute Lung Injury
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage in Patients Requiring Mechanical Ventilation in Intensive Care Unit

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Bronchoalveolar lavage fuid Nasal sample Peripheral mononuclear blood cells Plasma Serum


Enrollment: 30
Study Start Date: October 2009
Study Completion Date: April 2011
Groups/Cohorts
Influenza A/H1N1 patients
Non influenza A/H1N1 patients

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089400

Locations
France
Pitie-Salpetrière Hospital
Paris, France
Tenon Hospital
Paris, France
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Institut Pasteur
Investigators
Principal Investigator: Amelie Guihot, MD PhD INSERM UMR945
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01089400     History of Changes
Other Study ID Numbers: C09-39
Study First Received: March 17, 2010
Last Updated: January 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
influenza
H1N1
lymphocytes
T cell
CD4
CD8
 cytokine
serology
broncho-alveolar lavage
acute respiratory distress syndrome
ventilation
intensive care unit

Additional relevant MeSH terms:
Influenza, Human
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013