A Phase II, Open Label, Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Artesunate in Adults With Uncomplicated Malaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Percentage of Parasites Detected at 48 Hours
研究概览
简要总结
The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.
详细描述
This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male & non-pregnant females, 18-65 years
- •Fever, defined as >37.5ºC, during the current illness, or history (within the last 48 hours) of fever.
- •Diagnosis of falciparum malaria, greater than or equal to 200 parasites/uL
- •Able to communicate well with the investigator and to comply with the requirements of the entire study.
- •Willing to be admitted for the period of drug administration and/or to follow up (return to hospital)
- •Provision of the written informed consent to participate as shown by a signature on the informed consent form.
排除标准
- •Administration of any investigational drug in the period 0 to 16 weeks before entry to the study.
- •The use of any medication during the period 0 to 14 days (prescribed drugs) or 0 to 5 days (OTC) before entry to the study (including herbal or dietary supplements), except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study.
- •Existence of any surgical or medical condition that, in the judgment of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug.
- •History of serious adverse reaction or hypersensitivity to study drug or follow on treatment.
- •Mixed malaria infection (malaria other than falciparum malaria mono-infection as detected by screening blood smear)
- •Severe falciparum malaria (as defined by the WHO; Attachment 1).
- •Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study,
- •Transfusion of blood within past 30 days.
- •Refusal to prevent pregnancy during the 14 days of the trial
- •Pregnancy as defined clinically or by a positive urine BHCG at the time of screening, or nursing mothers.
- •Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary lab values:
- •Creatinine >1.4 x ULN (>2.0 mg/dL)
- •Glucose <LLN (65mg/dL)
- •AST, ALT >3x ULN (120 U/L)
研究组 & 干预措施
Artesunate and Malarone
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
干预措施: Artesunate (Drug)
Artesunate and Malarone
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
干预措施: Malarone (Drug)
结局指标
主要结局
Change in Percentage of Parasites Detected at 48 Hours
时间窗: 48 hours
Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases
次要结局
- Safety - Severity of Adverse Events(up to 14 days)
- Percentage of Parasite Clearance(24 and 48 hours post dose)
- Number of Subjects With Fever Clearance(Within 48 hours post dose)
- Safety - Adverse Events Relationship to Study Drug(up to 14 days)
- Safety - Severity of Serious Adverse Events (SAE's)(up to 14 days)
- Safety - Serious Adverse Event (SAE) Relationship to Study Drug(Up to 14 days)