An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older.

Novartis Pharmaceuticals0 个研究点目标入组 265 人开始时间: 2005年6月1日最近更新: 2012年4月27日

适应症

试验速览

阶段: 4 期
状态: 终止
发起方: Novartis Pharmaceuticals
入组人数: 265
主要终点: Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

To evaluate the effects of artemether/ lumefantrine on the auditory function.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 12 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•12 years of age or older
•P. falciparum parasitemia between 50 and 100,000 parasites/μl
•History of fever or presence of fever (temperature ≥ 37.5°C)

排除标准

•Signs/symptoms of severe/complicated malaria
•Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
•History of any drug-related hearing impairment.
•Abnormal hearing function at study entry
•Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems
•(Other protocol-defined inclusion/exclusion criteria may apply.)

结局指标

主要结局

Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).

次要结局

Relationship between changes in auditory function and drug exposure.
Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)
Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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