Immuno-virological Characterization of Severe H1N1v Influ... | NCT01089400

Studies
Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage

NCT01089400

Sponsor

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

Status

Completed

Last Update Posted

Dec 4, 2025Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Influenza
Acute Lung Injury
Acute Respiratory Distress Syndrome

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Mar 17, 2010

First Submission Date that Met QC Criteria

Mar 17, 2010

First Posted Date

Mar 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 4, 2025Actual

Name	Class
Assistance Publique - Hôpitaux de Paris	OTHER
Institut Pasteur	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
immunological parameters in blood and bronchoalveolar lavage fluid		day 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amelie Guihot, MD PhD	INSERM UMR945	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pitie-Salpetrière Hospital		Paris			France
Tenon Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24646009	Result	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.

Label	Type	Description	Intervention Names
Influenza A/H1N1 patients
Non influenza A/H1N1 patients

ID	Term
D007251	Influenza, Human
D055371	Acute Lung Injury
D012128	Respiratory Distress Syndrome
D053120	Respiratory Aspiration

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections