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Completed

NCT Number: NCT01418287

Characterization of Influenza-like Illness in Mexico

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General y de Alta Especialidad Dr. Manuel Gea González, México, State of Mexico, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses

    Time frame: 5 years

    Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment

Secondary outcomes

  1. Death

    Time frame: 5 years

    For all participants, to estimate the percentage who die

  2. Hospitalization

    Time frame: 5 years

    For all participants, to estimate the percentages who require hospitalization due to severe influenza

  3. Risk factors

    Time frame: 5 years

    For all participants, to determine risk factors for severe disease

  4. Repository of oropharyngeal and nasal samples

    Time frame: 5 years

    Establish a repository of oropharyngeal and nasal samples to determine a precise diagnosis, to molecularly characterize the virus

  5. Repository of serum and PBMC

    Time frame: 5 years

    Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza

Sponsors and collaborators

Lead sponsor

Mexican Emerging Infectious Diseases Clinical Research Network

Network

Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"
  • Hospital General Dr. Manuel Gea González
  • Hospital Infantil de Mexico Federico Gomez
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Instituto Nacional de Enfermedades Respiratorias
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Pediatrics, Mexico
  • Secretaria de Salud, Mexico

Registry information

Official study title

An Observational Study to Characterize Children and Adults With Influenza Like Illness (ILI) in Mexico

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2011
Registry last updated
Sep 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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