Estimating the Burden of Mycetoma: A Retrospective Analysis of Hospital Records
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Presence of mycetoma disease as evidenced by patient diagnosis
研究概览
简要总结
The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period. The main objectives are to:
- Determine the number of mycetoma cases diagnosed per year and trends over time.
- Describe characteristics of diagnosed mycetoma cases.
- Describe demographic characteristics of patients with mycetoma.
- Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.
- Assess etiology of mycetoma cases.
- Characterize clinical management of mycetoma cases.
- Characterize approaches to diagnosis of mycetoma.
- Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.
- Describe clinical outcomes among patients with mycetoma.
The study team will review all available medical, laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data.
详细描述
Mycetoma is a poorly understood neglected tropical disease which disproportionately affects the poorest of the poor and is associated with substantial morbidity. The disease presents a multitude of diagnostic and management challenges; in particular, effective treatments for eumycetoma, the fungal and least understood form of the disease are lacking. DNDi and partners aim to conduct late-phase clinical trials on a promising new pharmacologic treatment for eumycetoma, but substantial knowledge gaps preclude such trials. These knowledge gaps include data on the burden, distribution, causative agents, clinical presentation, natural history, and common approaches to diagnosis and treatment of mycetoma in endemic countries.
This study, a retrospective review of mycetoma cases, aims to generate such data from several countries suggested by preliminary data to potentially be good candidate clinical trial sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
排除标准
- •Patients with illegible or inaccessible health records.
结局指标
主要结局
Presence of mycetoma disease as evidenced by patient diagnosis
时间窗: Over 10 years
Sources: Medical records and/or laboratory records and/or radiologic records.
次要结局
- Presence of mycetoma disease after treatment or surgery(Over 10 years)
- Lesion size in centimeters(Over 10 years)