Characterization of Influenza-like Illness in Mexico

This study is currently recruiting participants.
Verified January 2013 by Mexican Infectious Disease Network
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: January 25, 2013
Last verified: January 2013
  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: April 2015
Estimated Primary Completion Date: April 2015 (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 nasopharyngeal swab
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418287

Contacts
Contact: Arturo Galindo Fraga, Dr. (52) 55 5487 0900 ext 2420
Contact: Ana Alejandra Ortiz Hernández (52) 55 1084 0900 ext 1616

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) Recruiting
Mexico City, Mexico, CP 14000
Contact: Diana Aguilar Cruz     (52) 55 5487 0900 ext 2420        
Principal Investigator: Arturo Galindo Fraga, Dr.            
Sub-Investigator: Bricia Roa            
Sub-Investigator: Itzel Cruz            
Hospital General y de Alta Especialidad Dr. Manuel Gea González Recruiting
Mexico City, Mexico, CP 14080
Contact: Ana Laura Corona     (52) 55 4000 3000 ext 3288        
Principal Investigator: Rafael Valdéz Vázquez, Dr.            
Principal Investigator: Irma Jiménez Escobar, Dr.            
Sub-Investigator: Patricia Rodríguez Zuleta            
Sub-Investigator: Javier Reyes Mar            
Sub-Investigator: Lorena Hernández Delgado            
Sub-Investigator: Jose Alfonso Maya            
Hospital Infantil de México Federico Gómez (HIM) Recruiting
Mexico City, Mexico, CP 06720
Contact: Mónica González     (52) 55 5228 9917 ext 2350        
Principal Investigator: Sarbelio Moreno            
Sub-Investigator: Rómulo Erick Rosales Uribe            
Sub-Investigator: Luis Mendoza            
Instituto Nacional de Enfermedades Respiratorias (INER) Recruiting
Mexico City, Mexico, CP 14080
Contact: Paulina Paulin     (52) 55 5487 1700 ext 5295        
Principal Investigator: Alejandra Ramírez            
Sub-Investigator: Nora Bautista            
Sub-Investigator: Rafael Hernández            
Sub-Investigator: Alejandra Velázquez            
Instituto Nacional de Pediatría (INP) Recruiting
Mexico City, Mexico, CP 04530
Contact: Diana Andrade     (52) 55 3520 9755        
Principal Investigator: Beatriz Llamosas            
Sub-Investigator: Ana Alejandra Ortiz Hernández            
Sub-Investigator: Angel Manuel Santa Cruz Castañeda            
Hospital Central Dr. Ignacio Morones Prieto Not yet recruiting
San Luis Potosí, Mexico, CP 78240
Contact: Evelyn Sánchez     (52) 444 172 360 ext 108        
Principal Investigator: Martin Magaña Aquino            
Sub-Investigator: Luis Fernando Pérez            
Sub-Investigator: Javier Araujo Meléndez            
Sub-Investigator: Alejandro Gómez Gómez            
Sub-Investigator: Daniel Ernesto Noyola Cherpitel            
Sub-Investigator: Christian Alberto García Sepúlveda            
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 Ciencia Medica y Nutrición Salvador Zubirán
Principal Investigator: Ana Alejandra Ortiz Hernández, Dr. Instituto Nacional de Pediatría
  More Information

No publications provided

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: January 25, 2013
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 May 22, 2013