Characterization of Influenza-like Illness in Mexico

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

Study Overview

• Status: Completed
• Conditions: Influenza-like Illness

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.

• Study Type: Observational
• Enrollment (Actual): 5819

Contacts and Locations

Study Locations

• Mexico
  • San Luis Potosí, Mexico, CP 78240
    • San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí
  • México
    • México City, México, Mexico, CP 04530
      • Instituto Nacional de Pediatría (INP)
    • México City, México, Mexico, CP 06720
      • Hospital Infantil de Mexico Federico Gomez (HIM)
    • México City, México, Mexico, CP 14000
      • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
    • México City, México, Mexico, CP 14080
      • Hospital General y de Alta Especialidad Dr. Manuel Gea González
    • México City, México, Mexico, CP 14080
      • Instituto Nacional de Enfermedades Respiratorias (INER)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hospitalized; Subjects who are hospitalized due to influenza-like illness
Non-hospitalized; Subjects who are not hospitalized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses	Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	For all participants, to estimate the percentage who die	5 years
Hospitalization	For all participants, to estimate the percentages who require hospitalization due to severe influenza	5 years
Risk factors	For all participants, to determine risk factors for severe disease	5 years
Repository of oropharyngeal and nasal samples	Establish a repository of oropharyngeal and nasal samples to determine a precise diagnosis, to molecularly characterize the virus	5 years
Repository of serum and PBMC	Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza	5 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Galindo-Fraga A, Guerra-de-Blas PDC, Ortega-Villa AM, Mateja A, Ruiz Quinones JA, Ramos Cervantes P, Ledesma Barrientos F, Ortiz-Hernandez AA, Llamosas-Gallardo B, Ramirez-Venegas A, Valdez Vazquez R, Noyola Chepitel D, Moreno-Espinosa S, Powers JH, Guerrero ML, Ruiz-Palacios GM, Beigel JH; Mexican Emerging Infectious Diseases Network. Different Clinical Presentations of Human Rhinovirus Species Infection in Children and Adults in Mexico. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac303. doi: 10.1093/ofid/ofac303. eCollection 2022 Jul.
• Galindo-Fraga A, Ortiz-Hernandez AA, Ramirez-Venegas A, Vazquez RV, Moreno-Espinosa S, Llamosas-Gallardo B, Perez-Patrigeon S, Salinger M, Freimanis L, Huang CY, Gu W, Guerrero ML, Beigel J, Ruiz-Palacios GM; La Red ILI 002 Study Group. Clinical characteristics and outcomes of influenza and other influenza-like illnesses in Mexico City. Int J Infect Dis. 2013 Jul;17(7):e510-7. doi: 10.1016/j.ijid.2013.01.006. Epub 2013 Feb 14.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 17, 2011

Study Record Updates

• Last Update Posted (Estimate): September 11, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: ILI002; HHSN272200900003I (Other Grant/Funding Number: National Institute of Allergy and Infectious Diseases)