Mpox, Biology, Outcome, Transmission and Epidemiology - Prospective Follow-up of High-risk Contacts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Study human-to-human transmission of Mpox virus (MPXV) by determining the secondary attack rate (SAR) among high-risk contacts of index patients.
研究概览
简要总结
With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. The study will take place in Maniema Province, Democratic Republic of Congo (DRC). Participants will be recruited among high-risk contacts of mpox patients included in the PALM-007 trial. Consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. They will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (PCR) and/or serology. If participants develop mpox, they are offered treatment and enrollment in the PALM-007 trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •▪ Be a high-risk contact of a laboratory-confirmed mpox case, with high-risk defined as having at least one the following types of exposure:
- •living in the same household as an mpox patient
- •having had sexual contact or intercourse with an mpox patient
- •sleeping in the same room as an mpox patient
- •sharing a meal with an mpox patient
- •children: having played together
- •Last exposure to the mpox index case of less than 14 days ago
- •Patients of any age and gender (children aged < 10 years are excluded from venous blood sampling)
- •Patient or culturally acceptable representative is willing and able to give informed consent for participation in the study
排除标准
- •Having previously been diagnosed with mpox in the last 3 months
- •Inability or unwillingness to comply with the proposed follow-up schedule
结局指标
主要结局
Study human-to-human transmission of Mpox virus (MPXV) by determining the secondary attack rate (SAR) among high-risk contacts of index patients.
时间窗: 21 days
Proportion of high-risk contacts with a positive MPXV PCR on any sample within 21 days after inclusion.
次要结局
- To estimate the extent of presymptomatic shedding of MPXV.(21 days)
- To estimate the duration between start of viral shedding and the appearance of prodromal symptoms.(21 days)
- To estimate the extent of asymptomatic shedding of MPXV.(21 days)
- To evaluate the protective effect of previous small pox vaccinations against infection and/or symptomatic disease.(21 days)
- To estimate the duration between start of viral shedding and the appearance of skin symptoms.(21 days)
- To determine the rate of seroconversion amongst high-risk contacts of index patients.(21 days)
- To estimate the incubation period of MPXV.(21 days)
- To characterize the clinical presentation of symptomatic secondary cases.(21 days)
- To evaluate risk factors for infection and/or symptomatic disease.(21 days)