Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR

Официальное название

Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR"

Обзор

Nonhuman primates (NHPs) constitute an important reservoir of infectious agents, some of which have emerged in human populations as deadly pathogens. Human exposure to the biological fluids of NHPs - particularly through bites - can result in the transmission of several viruses. Only the rabies virus is currently targeted by post-exposure prophylaxis following an injury caused by an NHP. The objective of the study is to investigate the prevalence of STLV-1 and SFV infections following a nonhuman primate bite.

Подробное описание

Nonhuman primates (NHPs) constitute an important reservoir of infectious agents, some of which have emerged in human populations as deadly pathogens. Human exposure to the biological fluids of NHPs - particularly through bites - can result in the transmission of several viruses. Only the rabies virus is currently targeted by post-exposure prophylaxis following an injury caused by an NHP.

Compared to other individuals exposed to nonhuman primates (NHPs), travelers have two unique characteristics. First, they are typically exposed only once to simian infectious agents, in contrast to the repeated exposure experienced by other at-risk groups. If exposure results in an infection event, travelers may spread these infectious agents to geographic areas where they do not normally circulate.

To address the following main objective: to study the prevalence of STLV-1 and SFV infections following a nonhuman primate bite. The study plans to include subjects who have been recently bitten as well as those with a history of nonhuman primate bites. Blood and saliva samples will be collected from the subjects.

Вмешательства

• Процедура Blood samples collection
  Blood samples of 40 ml will be taken.
• Процедура Saliva samples collection
  Saliva samples will be collected

Первичные конечные точки

• Study the prevalence of STLV-1 and SFV infections following an NHP bite. [Срок оценки: 17 months]

Вторичные конечные точки (1)

• Identify risk and demographic factors associated with STLV-1 and SFV infection. [Срок оценки: 17 months]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Bite inflicted by an HNP (WHO category 3 level)
• Written informed consent
• Affiliation with a social security scheme (excluding State Medical Aid

Specific criteria for genetic analyses:

• Participant has checked the boxes for participation in the genetic component.

Критерии исключения

• Patient presenting only with scratches inflicted by a PNH
• Medical management incompatible with the objectives of the study
• Patient who, in the doctor's opinion, is unlikely to comply with the study protocol
• Health conditions are incompatible with the sample collection required by the study
• Patient under legal protection (guardianship or trusteeship)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Institut Pasteur Medical Center — Paris

Идентификаторы

NCT: NCT07097480 · 2024-113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗