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临床试验/NCT05784038
NCT05784038招募中不适用

Observational, Prospective, Cohort Study of Mpox Infection in Brazil - NETPOX Cohort

Hospital Israelita Albert Einstein3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
3
主要终点
Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions

研究概览

简要总结

The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged ≥ 18 years with confirmed MPOX infection.
  • (laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization)

排除标准

  • Inability to provide informed consent;
  • Patient who, judging by the study team, does not have a condition for decentralized follow-up

结局指标

主要结局

Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions

时间窗: Up to 90 days after the inclusion

symptoms' incidence in participants with mpox infection

次要结局

  • Hospitalizations(Days 15, 30, 60, and 90)
  • Untargeted metabolomics of total plasmas and skin lesion(Days 15, 30, 60, and 90)
  • Viral genomic(Day 0)
  • Death(Up to 90 days after the inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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