Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients (ANRS 2H)
Primary Purpose
HIV Infections, Influenza
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
naso-pharyngeal swab
Sponsored by
About this trial
This is an interventional other trial for HIV Infections
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
Sites / Locations
- 34 ANRS center
Outcomes
Primary Outcome Measures
Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).
Secondary Outcome Measures
Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
Full Information
NCT ID
NCT01039220
First Posted
December 22, 2009
Last Updated
April 27, 2017
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
1. Study Identification
Unique Protocol Identification Number
NCT01039220
Brief Title
Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients
Acronym
ANRS 2H
Official Title
Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Influenza
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1266 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
naso-pharyngeal swab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).
Secondary Outcome Measure Information:
Title
Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genevieve CHENE
Organizational Affiliation
INSERM U897 BORDEAUX
Official's Role
Principal Investigator
Facility Information:
Facility Name
34 ANRS center
City
Paris + region of country
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.anrs.fr
Description
(legal sponsor's website)
Learn more about this trial
Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients
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