Clinical trial NCT01418287: Characterization of Influenza-like Illness in Mexico
Official title: An Observational Study to Characterize Children and Adults With Influenza Like Illness (ILI) in Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza-like Illness
Lead sponsor: Mexican Emerging Infectious Diseases Clinical Research Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Secretaria de Salud, Mexico
name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Instituto Nacional de Enfermedades Respiratorias
name: National Institute of Pediatrics, Mexico
name: Hospital General Dr. Manuel Gea González
name: Hospital Infantil de Mexico Federico Gomez
name: Hospital Central "Dr. Ignacio Morones Prieto"
First posted: 2011-08-17
Enrollment: 5819
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with influenza-like illness presenting to clinical sites in Mexico

Brief 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.

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 criteria: 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.

Primary outcomes:
measure: Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses
timeFrame: 5 years
Secondary outcomes:
measure: Death
timeFrame: 5 years
measure: Hospitalization
timeFrame: 5 years
measure: Risk factors
timeFrame: 5 years
measure: Repository of oropharyngeal and nasal samples
timeFrame: 5 years
measure: Repository of serum and PBMC
timeFrame: 5 years
Other outcomes:
Locations:
city: México City
country: Mexico
facility: Instituto Nacional de Pediatría (INP)
state: México
city: México City
country: Mexico
facility: Hospital Infantil de México Federico Gómez (HIM)
state: México
city: México City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
state: México
city: México City
country: Mexico
facility: Hospital General y de Alta Especialidad Dr. Manuel Gea González
state: México
city: México City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias (INER)
state: México
city: San Luis Potosí
country: Mexico
facility: San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí
Study officials:
affiliation: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
name: Arturo Galindo Fraga, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Pediatría
name: Ana Alejandra Ortiz Hernández, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.