Clinical Trial: A Study to Determine the Causes and Identify Increases in Influenza-Like Illness (ILI) in Mexico

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: An Observational Study to Determine the Causes and Identify Increases in Influenza-Like Illness (ILI) in Mexico: The Mexican Emerging Infectious Disease Clinical Research

Brief Summary: The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and Severe Acute Respiratory Infection (SARI), describe seasonal pattern of the pathological agents associated with ILI and SARI and to identify changes in severity of disease caused by a specific agent.

Detailed Summary:

The La Red Network clinical sites will enroll individuals presenting with ILI symptoms. A systematic sample will be chosen across all sites, with the goal of choosing 3 subjects who are outpatients and 3 subjects who are hospitalized every week at each site. It is recognized that, during seasons of low ILI activity, this enrollment goal may not be achieved. To be eligible for selection, subjects must be willing to sign informed consent, or provide informed consent/assent in the case of minors.

Subjects will be followed for a period of 28 days after enrollment to assess vital status. It is estimated that this study will enroll a maximum of 1872 subjects per year for an approximate 7488 subjects in the four years that the study proposes to enroll, depending upon the extent of ILI occurring during the period of this study.

Nasopharyngeal swabs, sputum samples, and blood samples will be obtained at enrollment. The nasopharyngeal swabs and, in adults > 18 years of age, portion of the blood for serum and peripheral blood mononuclear cells (PBMC) will be obtained for storage and shipped to the central repository located at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán for respiratory pathogen testing including real-time Polymerase Chain Reaction (PCR) and multiplex techniques.

All enrolled subjects will be assessed at enrollment, at 7 days (+3 days) and at 28 days (+/- 5 days) after enrollment to assess disease resolution and vital status.

The purpose of the study is to provide information regarding the pathogens causing ILI among patients seeking care at the La Red Network sites. The systematic collection of data over time will allow for the determination of seasonal patterns of differen
Sponsor: Mexican Emerging Infectious Diseases Clinical Research Network

Current Primary Outcome: Etiologic agents causing ILI and SARI among patients seeking medical care at participating sites in Mexico. [ Time Frame: 4 years ]

Difference in the proportion of a determined isolated etiologic agent (or hospitalization) in the current 2 weeks (increases) in relation to the prior 8 weeks


Original Primary Outcome: Etiologic agents causing ILI and SARI among patients seeking medical care at participating sites in Mexico. [ Time Frame: 4 years ]

Difference in the proportion of a determined isolated etiologic agent (or hospitalization) in the current two weeks (increases) in relation to the prior 8 weeks


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mexican Emerging Infectious Diseases Clinical Research Network

Dates:
Date Received: February 16, 2015
Date Started: January 2015
Date Completion:
Last Updated: November 9, 2016
Last Verified: November 2016