跳至主要内容
临床试验/NCT01418287
NCT01418287已完成不适用

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

Mexican Emerging Infectious Diseases Clinical Research Network6 个研究点 分布在 1 个国家目标入组 5,819 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,819
试验地点
6
主要终点
Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses

时间窗: 5 years

Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment

次要结局

  • Risk factors(5 years)
  • Hospitalization(5 years)
  • Repository of oropharyngeal and nasal samples(5 years)
  • Death(5 years)
  • Repository of serum and PBMC(5 years)

研究者

发起方
Mexican Emerging Infectious Diseases Clinical Research Network
申办方类型
Network
责任方
Sponsor

研究点 (6)

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