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

January 27, 2012 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Pitie-Salpêtrière Hospital
      • Paris, France
        • Tenon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Influenza A/H1N1 patients
Non influenza A/H1N1 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
day 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood

Secondary Outcome Measures

Outcome Measure
Time Frame
virological parameters in nose, broncho-alveolar lavage and peripheral blood
Time Frame: day 0 and day 5-7 of ventilation
day 0 and day 5-7 of ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Assistance Publique - Hôpitaux de Paris
Institut Pasteur

Investigators

  • Principal Investigator: Amelie Guihot, MD PhD, INSERM UMR945

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C09-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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