Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage (NCT01089400) | Clinical Trial Compass
CompletedNot Applicable
Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage
France30 participantsStarted 2009-10
Plain-language 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 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.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
immunological parameters in blood and bronchoalveolar lavage fluid
Timeframe: day 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood
Trial details
NCT IDNCT01089400
SponsorInstitut National de la Santé Et de la Recherche Médicale, France