Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients (ANRS 2H)
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|ClinicalTrials.gov Identifier: NCT01039220|
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : April 28, 2017
To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in French HIV infected patients.
- Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia. (Centers for Disease Control definition).
- Serious forms of influenza-like illness is defined by hospitalization within 14 days onset of symptoms or death attributed to influenza like illness.
- Survey sampling for estimating H1N1v influenza-like illness incidence.
- Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres, a sub-group will be selected by random sampling. Sampling will be stratified by centre and sampling fraction per site will vary in order to select 60 to 80 patients for this study per site. A total of 2500 to 3000 patients will be selected to allow for estimating the incidence of H1N1v influenza-like illness with an adequate precision.
Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.
Nested case-control study for the determination of risk factors for serious forms:
- Cases: Serious forms (see definition above) identified by any clinical site or hospitalisation unit.
- Controls: Patients of the randomly selected sample (see survey sampling above), presenting with influenza-like illness without any criterion for severity.
The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Influenza||Biological: naso-pharyngeal swab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1266 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Biological: naso-pharyngeal swab
- Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).
- Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039220
|34 ANRS center|
|Paris + region of country, France|
|Principal Investigator:||Genevieve CHENE||INSERM U897 BORDEAUX|