NCT01374126已完成2 期
Azithromycin Combination Therapy for the Treatment of Severe Malaria - A Pilot Safety and Efficacy Study in Uncomplicated Falciparum Malaria in Bangladesh
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Safety and Tolerability (Number of Participants with Adverse Events)
研究概览
简要总结
A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh.
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
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants with a diagnosis of acute falciparum malaria meeting all criteria listed below may be included in the study:
- •Acute symptomatic falciparum malaria infection with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5ºC), or reported history of fever within the last 48 hours.
- •Age: 8-65 years old
- •Males or females. All females over the age of 12 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
- •Written informed consent obtained
- •Willing to stay under close medical supervision for the study duration
- •Otherwise healthy outpatients
排除标准
- •Participants presenting with any of the following will not be included in the study:
- •Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3)
- •Mixed malaria infection on admission by malaria smear
- •A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin or to drugs with similar chemical structures
- •Malaria drug therapy administered in the past 30 days by history
- •History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
- •Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
- •Signs or symptoms of severe malaria (as defined by WHO 2003)
- •Unable and/or unlikely to comprehend and/or follow the protocol
研究组 & 干预措施
Azithromycin-Artesunate
Experimental
干预措施: Azithromycin + Artesunate (Drug)
Control (artesunate alone)
Active Comparator
干预措施: Artesunate (Drug)
结局指标
主要结局
Safety and Tolerability (Number of Participants with Adverse Events)
时间窗: 42 days
Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42
时间窗: 42 days
次要结局
未报告次要终点
研究者
Harald Noedl
Assoc. Prof. Dr.
Medical University of Vienna
研究点 (1)
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