Characterization of Influenza-like Illness in Mexico

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Secretaria de Salud, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Enfermedades Respiratorias
National Institute of Pediatrics, Mexico
Hospital General Dr. Manuel Gea González
Hospital Infantil de Mexico Federico Gomez
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Mexican Infectious Disease Network
ClinicalTrials.gov Identifier:
NCT01418287
First received: August 15, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition
Influenza-like Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Characterize Children and Adults With Influenza Like Illness (ILI) in Mexico

Resource links provided by NLM:


Further study details as provided by Mexican Infectious Disease Network:

Primary Outcome Measures:
  • Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment


Secondary Outcome Measures:
  • Death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    For all participants, to estimate the percentage who die

  • Hospitalization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    For all participants, to estimate the percentages who require hospitalization due to severe influenza

  • Risk factors [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    For all participants, to determine risk factors for severe disease

  • Repository of oropharyngeal and nasal samples [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Establish a repository of oropharyngeal and nasal samples to determine a precise diagnosis, to molecularly characterize the virus

  • Repository of serum and PBMC [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza


Biospecimen Retention:   Samples With DNA

Plasma, PBMC and Nasopharingeal aspirates


Estimated Enrollment: 5000
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hospitalized
Subjects who are hospitalized due to influenza-like illness
Non-hospitalized
Subjects who are not hospitalized

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with influenza-like illness presenting to clinical sites in Mexico

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418287

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
México City, México, Mexico, CP 14000
Hospital General y de Alta Especialidad Dr. Manuel Gea González
México City, México, Mexico, CP 14080
Hospital Infantil de México Federico Gómez (HIM)
México City, México, Mexico, CP 06720
Instituto Nacional de Enfermedades Respiratorias (INER)
México City, México, Mexico, CP 14080
Instituto Nacional de Pediatría (INP)
México City, México, Mexico, CP 04530
San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí
San Luis Potosí, Mexico, CP 78240
Sponsors and Collaborators
Mexican Infectious Disease Network
Secretaria de Salud, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Enfermedades Respiratorias
National Institute of Pediatrics, Mexico
Hospital General Dr. Manuel Gea González
Hospital Infantil de Mexico Federico Gomez
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
Principal Investigator: Arturo Galindo Fraga, Dr. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
Principal Investigator: Ana Alejandra Ortiz Hernández, Dr. Instituto Nacional de Pediatría
  More Information

No publications provided by Mexican Infectious Disease Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mexican Infectious Disease Network
ClinicalTrials.gov Identifier: NCT01418287     History of Changes
Other Study ID Numbers: ILI002, HHSN272200900003I
Study First Received: August 15, 2011
Last Updated: April 16, 2014
Health Authority: Mexico: Ethics Committee
Mexico: Ministry of Health

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014