NCT00082563终止2 期
A Phase II, Randomized, Comparative Trial Of Azithromycin In Combination With Chloroquine Versus Chloroquine In The Eradication Of Asymptomatic Plasmodium Falciparum Infection In Semi-Immune Adults
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 14
- 主要终点
- Parasite clearance
研究概览
简要总结
The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.
详细描述
The trial was terminated prematurely 9 November 2004 due to the inability to recruit the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult: male or female
- •Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/μL
- •Age 18 years to 60 years
- •Willingness to sign and ability to understand consent form
- •Willingness and ability to return for scheduled follow up visits
排除标准
- •Mixed malaria infection by Giemsa smear
- •History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin)
- •Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study
- •Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting)
- •Inability to swallow oral medication
- •Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality
- •Any situation which could prevent the patient from returning to follow up visits
- •Pregnancy or breast feeding
- •Any other concurrent illness that may confound the result
- •Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study
结局指标
主要结局
Parasite clearance
次要结局
- tolerability
研究者
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