Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.
详细描述
Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 5 years
- •Uncomplicated falciparum malaria
- •Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
- •Ability to tolerate oral therapy
- •Informed consent by the patient or by parent/guardian for children
- •Residence in study area
排除标准
- •Known or suspected hearing deficits
- •Adequate anti-malarial treatment within the previous 7 days
- •Mixed infection
- •Danger signs and signs of severe malaria as defined by the WHO
- •Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
- •Concomitant disease masking assessment of response
- •History of allergy or intolerance against study medications
- •Pregnancy