Characterization of Influenza-like Illness in Mexico
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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 |
- 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
- 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 |
Patients with influenza-like illness presenting to clinical sites in Mexico
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| Contact: Arturo Galindo Fraga, Dr. | (52) 55 5487 0900 ext 2420 | |
| Contact: Ana Alejandra Ortiz Hernández | (52) 55 1084 0900 ext 1616 |
| 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 | |
| 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