Characterization of Influenza-like Illness in Mexico

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5819 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-05-31

Brief Summary

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A study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with H1N1.

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Detailed Description

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In March 2009, a new influenza A virus, novel H1N1 (commonly referred to as "swine flu"), began causing an increase in reports of influenza-like illness in North America. Although the virus subsequently spread rapidly around the world, the earliest reported outbreak of cases occurred in Mexico City, which is seen as the epicenter of the influenza pandemic, the world's first in 40 years.

Many questions remain about this emerging pandemic and the virus causing it, the answers to which could better inform patient management and policy decisions both in Mexico and internationally. Sparse reliable clinical research data have been collected on the natural history of the disease, on the risk factors associated with severe disease, or on the severity of this pandemic influenza as compared to seasonal influenzas. This study is an initial step to better characterize individuals in Mexico who develop influenza-like illness (including illness caused by novel H1N1), to describe the clinical management of those individuals, and to assess their short-term outcome. The planned data collection will provide timely information to inform policy and guidelines for the local populations and governments involved and may also be used to design future ancillary studies of this influenza virus and/or studies of other emerging infectious diseases.

The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and to describe clinical course over a period of at least 28 days after enrollment.

Conditions

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Influenza-like Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospitalized

Subjects who are hospitalized due to influenza-like illness

No interventions assigned to this group

Non-hospitalized

Subjects who are not hospitalized

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent by participant, or for pediatric participants, signed informed consent by parent/legal guardian and, where appropriate, signed assent by participant
* At least one respiratory symptom (e.g., shortness of breath, postnasal drip, cough) and
* One of the following criteria:
* Fever (≥ 38 °C by any method: oral, axillary, etc.) on examination or participant-reported fever (≥ 38° C) or feverishness in the past 24 hours
* One or more non-respiratory symptoms (e.g., malaise, headache, myalgia,chest pain)
* Consenting to provide aspirate or naso-pharyngeal swab

Exclusion Criteria

* The onset of illness is more than 48 hours after hospitalization.
* Participants previously included in this study within the last 30 days.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arturo Galindo Fraga, Dr.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

Ana Alejandra Ortiz Hernández, Dr.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Pediatría

Locations

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