Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
研究概览
简要总结
The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.
详细描述
In view of spreading antimalarial drug resistance there is an urgent need for new combination treatments for a disease that kills more than one million people every year. Azithromycin is a macrolide antibiotic that is particularly attractive due to its safety in children and experience with use in pregnancy. Recent trials suggest that azithromycin has a strong potential as an antimalarial. The purpose of this study is to investigate the efficacy of azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in 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
- •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
- •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 lumefantrine or to drugs with similar chemical structures
- •Malaria drug therapy administered in the past 30 days by history
- •Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
- •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
Azithromycin + Artesunate treatment
干预措施: azithromycin plus artesunate (Drug)
Artesunate
Artesunate treatment controls
干预措施: Artesunate (Drug)
结局指标
主要结局
Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
时间窗: 42 days
次要结局
- Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).(42)
研究者
Harald Noedl
Assoc. Prof.
Medical University of Vienna