Clinical trial NCT01039220: Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients
Official title: Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Influenza
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2009-12-24
Enrollment: 1266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

* Definitions:

  * 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.
* Design:

  * 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.

Exhaustivity check:

The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Able to give written consent
* Covered by French Social Security
* HIV-infected (infection attested by the patient's chart)
* pregnant women

  * Control and sample to estimate incidence
* Patients followed for their HIV-infection in an ANRS center

  * Serious form
* Hospitalization whatever is the service in 14 days consecutive to a H1N1v influenza syndrome such as defined, or death consecutive to a H1N1v influenza syndrome such as defined.

Exclusion Criteria:

* patients for whom a H1N1v influenza syndrome can be informed at the beginning of the study.
* Under protection(saving) of justice

Primary outcomes:
measure: Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).
Secondary outcomes:
measure: Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
Other outcomes:
Locations:
city: Paris + region of country
country: France
facility: 34 ANRS center
Study officials:
affiliation: INSERM U897 BORDEAUX
name: Genevieve CHENE
role: PRINCIPAL_INVESTIGATOR
References: