Characterization of Influenza-like Illness in Mexico

Influenza-like Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418287
• Other study ID #: ILI002
• Secondary ID: HHSN272200900003
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: September 10, 2014
• Start date: April 2010
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Mexican Infectious Disease Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeMexico: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5819
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza, Human
• Influenza-like Illness

Locations

Country	Name	City	State
Mexico	Hospital General y de Alta Especialidad Dr. Manuel Gea González	México City	México
Mexico	Hospital Infantil de México Federico Gómez (HIM)	México City	México
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)	México City	México
Mexico	Instituto Nacional de Enfermedades Respiratorias (INER)	México City	México
Mexico	Instituto Nacional de Pediatría (INP)	México City	México
Mexico	San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí	San Luis Potosí

Sponsors (9)

Lead Sponsor	Collaborator
Mexican Infectious Disease Network	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

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Death	For all participants, to estimate the percentage who die	5 years	No
Secondary	Hospitalization	For all participants, to estimate the percentages who require hospitalization due to severe influenza	5 years	No
Secondary	Risk factors	For all participants, to determine risk factors for severe disease	5 years	No
Secondary	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	No
Secondary	Repository of serum and PBMC	Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza	5 years	No