An observational study in Influenza-like Illness, sponsored by Mexican Emerging Infectious Diseases Clinical Research Network. Completed at 6 sites in Mexico. Per ClinicalTrials.gov, last updated 2014-09-11.
Sponsored by Mexican Emerging Infectious Diseases Clinical Research Network · Observational
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.
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.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 5,819 is above the median of 300 across 305 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →Mexican Emerging Infectious Diseases Clinical Research Network is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with influenza-like illness presenting to clinical sites in Mexico
Exclusion Criteria
Subjects who are hospitalized due to influenza-like illness
Subjects who are not hospitalized
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
Time frame: 5 years
Death
For all participants, to estimate the percentage who die
Time frame: 5 years
Hospitalization
For all participants, to estimate the percentages who require hospitalization due to severe influenza
Time frame: 5 years
Risk factors
For all participants, to determine risk factors for severe disease
Time frame: 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
Time frame: 5 years
Repository of serum and PBMC
Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza
Time frame: 5 years
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mexican Emerging Infectious Diseases Clinical Research Network