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临床试验/NCT05567939
NCT05567939终止不适用

Clinical, Virological, Serological and Psychosocial Outcomes in Human Monkeypox Virus Infectious Disease - a PROspective Observational Cohort Study for Epidemiology and Outcomes of MPXVID

Public Health Service of Amsterdam1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
What is the time to resolution of symptoms among patients with symptomatic MPXVID?

研究概览

简要总结

MonkeyPox Virus Infectious Disease (MPXVID) is a viral infection caused by the monkeypox virus (MPXV) which is an orthopoxvirus that is endemic in countries in West and Central Africa. The clinical course of the MPXVID is similar to smallpox (variola) but usually milder - with less severe disease symptoms seen in the West African subtype. Historically, the case fatality ratio of MPXVID ranged from 0 to 11% and fatality occurs more commonly among children. In Europe, human MPXVID only occurred as an imported disease with limited onward transmission. However, since May 2022 over 19.000 cases of MPXVID - mostly with the West African subtype - have been reported in Europe without a travel history to the endemic areas in Africa. The far large majority of patients with MPXVID in the current outbreak are gay, bisexual and other men who have sex with men (GBMSM). There is an urgent need to address essential knowledge gaps for optimal clinical care and public health management.

The aim of this study is to improve our understanding of clinical, virological, and psychosocial outcomes in patients with MPXVID. To get a better understanding of associated risk factors for MPXV infection, and to measure quality of life and stigma, the investigators will also include a control population of men without proctitis and MPXVID-related symptoms at day 0. In addition, the investigators want to assess the vaccine effectiveness against MPXVID of infant smallpox vaccination given before 1974, as well as vaccine effectiveness of the modified vaccinia Ankara (MVA) smallpox vaccine, when administered as pre- or post-exposure prophylaxis in high risk contacts of MPXVD patients.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

What is the time to resolution of symptoms among patients with symptomatic MPXVID?

时间窗: 28 days

The time between appearance of the first lesions and the day on which all skin lesions are epithelialized and crusts fall off, and all systemic symptoms (incl. proctitis) have resolved.

次要结局

  • To describe the presence of MPXV DNA and cycle threshold (Ct) values in patients with MPXVID.(180 days)
  • To describe changes in sexual behaviour in patients with MPXVID in comparison to controls.(180 days)
  • To describe the use of antiviral medication and/or immunoglobulins.(180 days)
  • To describe and analyse demographic characteristics in patients with MPXVID.(180 days)
  • To describe and analyse clinical characteristics in patients with MPXVID.(180 days)
  • To describe other virological outcomes in patients with MPXVID.(180 days)
  • To describe changes in quality of life in patients with MPXVID in comparison to controls.(180 days)
  • To describe changes in the physical and psychological health in patients with MPXVID in comparison to controls.(180 days)
  • To estimate the effectiveness against MPXVID of modified vaccinia Ankara (MVA) smallpox vaccine.(through study completion, an average of 1 year)
  • To describe and analyse other clinical characteristics in patients with MPXVID.(180 days)
  • To describe changes in the experience of (internalized) stigma in patients with MPXVID in comparison to controls.(180 days)
  • To describe changes in the experience of fatigue in patients with MPXVID in comparison to controls.(60 days)
  • To describe and analyse sexual characteristics in patients with MPXVID.(180 days)
  • To estimate the effectiveness against MPXVID of infant smallpox vaccine given before 1974.(through study completion, an average of 1 year)

研究者

发起方
Public Health Service of Amsterdam
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Henry J.C. de Vries

Professor Doctor

Public Health Service of Amsterdam

研究点 (1)

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