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临床试验/NCT05476744
NCT05476744已完成不适用

Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia5 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
5
主要终点
Viral clearance in blood

研究概览

简要总结

The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

详细描述

Starting in early May 2022 a large number of cases of Monkeypox have been reported in non-endemic countries. Although initial cases appeared to be linked to travel, the majority of subsequent cases appear to have no travel associated risk factors and these cases have predominantly occurred amongst Men who have Sex with Men (MSM) suggesting autochthonous transmission associated with sexual networks.

Monkeypox is known to be transmitted by close contact with skin lesions of infected individuals and/or via droplets. It is known that the virus can be detected from skin lesions, in blood, in throat swabs and on occasion urine samples. There is limited information as to whether the virus can be detected or persist in other sites including semen. Serial virological monitoring has been conducted in a small number of individuals and demonstrates that prolonged shedding for at least 2-3 weeks appears to be relatively common. To help control the current outbreak health authorities have used a number of strategies including identifying and isolating cases of monkeypox combined with contact tracing and limited use of ring-vaccination strategies. Because the number of cases seen outside of endemic areas has previously been limited, there is inadequate data to guide decision-making about the duration of isolation, but this is critical to the management of the current outbreak.

The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Viral clearance in blood

时间窗: From day 1 to day 57

Time to undetectable monkeypox viral load in blood (Number of days)

Viral clearance in rectum swabs

时间窗: From day 1 to day 57

Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)

Viral clearance in skin lesions

时间窗: From day 1 to day 57

Time to undetectable monkeypox viral load in skin lesions (Number of days)

Viral clearance in oropharyngeal swabs

时间窗: From day 1 to day 57

Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days)

Viral clearance in vaginal discharge

时间窗: From day 1 to day 57

Time to undetectable monkeypox viral load in vaginal discharge (Number of days)

Viral clearance in semen discharge

时间窗: From day 1 to day 57

Time to undetectable monkeypox viral load in semen (Number of days)

次要结局

  • Humoral responses against monkeypox(At baseline and 1, 3, and 6 months later)
  • Cellular responses against monkeypox(At baseline and 1, 3, and 6 months later)

研究者

发起方
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oriol Mitja

Associate Professor, Infectious Diseases and Global Heaelth

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

研究点 (5)

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