A Prospective Cohort Study on the Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis After Treatment for Primary Visceral Leishmaniasis in South Sudan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Epicentre
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of post-kala-azar-dermal leishmaniasis (PKDL)
研究概览
简要总结
This study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis.
详细描述
This prospective, observational cohort study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis from a hospital in Lankien, South Sudan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary visceral leishmaniasis patients who had a confirmed (serological and/or parasitological) diagnosis at admission, and who were discharged after successful treatment
- •Availability for follow up visits
- •Provision of informed consent, and in the case of minors 12 to 17 years of age, assent as well
排除标准
- •Unavailability for follow-up visits due to distance, inaccessibility, or refusal to participate
- •Diagnosis of prior primary visceral leishmaniasis done only on clinical basis
结局指标
主要结局
Incidence of post-kala-azar-dermal leishmaniasis (PKDL)
时间窗: 12 months
To determine the incidence of PDKL after initial successful treatment of primary visceral leishmaniasis (VL) over a period of 12 months
Incidence of VL relapse
时间窗: 12 months
To determine the incidence of VL relapse after initial successful treatment of primary VL over a period of 12 months
次要结局
- Characterize PKDL lesions(12 months)
- Time of onset of visceral leishmaniasis (VL) relapse or post-kala-azar-dermal leishmaniasis (PKDL)(12 months)
- Rate and time period to self-healing of PKDL(12 months)
- Risk factors for the development of VL relapse or PKDL(12 months)