InfluenzaFluBALNCT01089400
Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage
An observational study of Influenza and Acute Lung Injury, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Influenza, Acute Lung Injury, Acute Respiratory Distress Syndrome
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit
Who may be able to join
- 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
Who cannot join
- Other cause identified of acute lung injury or acute respiratory distress syndrome
- Contraindicated bronchoalveolar lavage
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Keywords
- influenza, H1N1, lymphocytes, T cell, CD4, CD8, cytokine, serology, broncho-alveolar lavage, acute respiratory distress syndrome, ventilation, intensive care unit
- Medical subject headings
- Influenza, Human, Acute Lung Injury, Respiratory Distress Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Influenza A/H1N1 patients | Not described | |
| Non influenza A/H1N1 patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunological parameters in blood and bronchoalveolar lavage fluid
Measured: 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
Measured: day 0 and day 5-7 of ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Amelie Guihot, MD PhD, Principal investigator, INSERM UMR945
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089400
- Sponsor's protocol ID
- C09-39
- Acronym
- FluBAL
- Status last verified
- Jan 2012
- First submitted
- 17 Mar 2010
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Guihot A, Luyt CE, Parrot A, Rousset D, Cavaillon JM, Boutolleau D, Fitting C, Pajanirassa P, Mallet A, Fartoukh M, Agut H, Musset L, Zoorob R, Kirilovksy A, Combadiere B, van der Werf S, Autran B, Carcelain G; FluBAL Study Group. Low titers of serum antibodies inhibiting hemagglutination predict fatal fulminant influenza A(H1N1) 2009 infection. Am J Respir Crit Care Med. 2014 May 15;189(10):1240-9. doi: 10.1164/rccm.201311-2071OC.
PubMed 24646009
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage in Patients Requiring Mechanical Ventilation in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01089400
- Acronym / sponsor ID
- FluBAL / C09-39
- Keywords
- influenza, H1N1, lymphocytes, T cell, CD4, CD8, cytokine, serology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Institut Pasteur
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza A/H1N1 patients | – | – |
| Non influenza A/H1N1 patients | – | – |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Other cause identified of acute lung injury or acute respiratory distress syndrome
- Contraindicated bronchoalveolar lavage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
virological parameters in nose, broncho-alveolar lavage and peripheral blood
Time frame: day 0 and day 5-7 of ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 24646009Guihot A, Luyt CE, Parrot A, Rousset D, Cavaillon JM, Boutolleau D, Fitting C, Pajanirassa P, Mallet A, Fartoukh M, Agut H, Musset L, Zoorob R, Kirilovksy A, Combadiere B, van der Werf S, Autran B, Carcelain G; FluBAL Study Group. Low titers of serum antibodies inhibiting hemagglutination predict fatal fulminant influenza A(H1N1) 2009 infection. Am J Respir Crit Care Med. 2014 May 15;189(10):1240-9. doi: 10.1164/rccm.201311-2071OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amelie Guihot, MD PhD principal investigator
INSERM UMR945
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Acute Lung Injury, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.