Efficacy, Safety and Tolerability of Co-artemether in Non-immune Travelers
2012年4月25日 更新者:Novartis Pharmaceuticals
Open-label, Multi-center, Non-comparative Efficacy, Safety, and Tolerability Study of Co-artemether in the Treatment of Acute Uncomplicated Malaria in Non-immune Patients
This study will assess the safety and efficacy of co-artemether in the treatment of acute uncomplicated P. falciparum malaria in returning non-immune travellers
THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES
研究概览
研究类型
介入性
阶段
- 第四阶段
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
描述
Inclusion Criteria:
Patients were eligible for inclusion if they met all of the following criteria:
- Male or female aged 18 or older (prior to Amendment 1: more than 2 years old)
- Non-immune patients suffering from acute uncomplicated P. falciparum malaria, or mixed infection including P. falciparum, with parasitemia of less than or equal to 2% asexual P.falciparum parasites, confirmed by microscopy using Giemsa-stained thick film.
- Non-immune patients were regarded as those who had not spent the first five years of their life, nor the last five years in a malaria endemic area, and did not have acute P. falciparum malaria diagnosed during those past five years.
- Non-immune patients who had received prophylaxis with anti-malarials (excluding halofantrine) were included only if clear progression of acute P. falciparum infection was documented.
- Female patients were eligible to participate in the study if they were of non-childbearing potential or had a negative pregnancy test (urine or serum) at screening, and using an acceptable contraceptive method
- Patients, who had been informed of the study procedures and medication, and had given written informed consent and were willing to comply with the study protocol.
Exclusion Criteria:
Patients were to be excluded from participation if they met any of the following criteria:
- Known hypersensitivity to artemether or lumefantrine
- Signs/symptoms indicative of severe/complicated malaria according to the WHO classification (e.g. cerebral malaria, see Post-text supplement 1)
- Treatment with artemisinin derivatives within the previous 7 days
- Concurrent administration of other treatment / prophylaxis for malaria
- Concurrent administration of medications with potential hemolytic effects
- Patients taking any drug metabolized by cytochrome isoenzymes CYP3A4 or CYP2D6
- Received any other investigational drugs in the last 4 weeks before entry into the study
- Severe cardiac impairment (i.e. evidence of existing cardiac conduction defect or overt symptoms of cardiac dysfunction or abnormalities of baseline ECG not associated with acute malaria); clinically relevant bradycardia or congestive cardiac failure with reduced left ventricular ejection fraction; pre-existing prolongation of the QT interval; history of symptomatic cardiac arrhythmias
- Having received halofantrine or any other drug known to influence cardiac function within 4 weeks prior to Screening visit or taking other drugs that are known to prolong the QT interval, including class IA and III antiarrhythmics, neuroleptics, antidepressive agents, certain antibiotics (including some macrolides, fluoroquinolones, imidazole, and triazole antifungal agents), certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride
- History of splenectomy
- Clinically significant abnormal baseline hematology (not associated with acute malaria) or clinical chemistry parameters, including evidence of hepatic or renal impairment, known disturbances of electrolyte balance e.g. hypokalemia or hypomagnesaemia
- Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study, or concomitant disease which could mask the response to treatment
- Unlikely, in the opinion of the investigator, to complete the dosing or follow-up periods, or who have evidence of alcohol, drug or solvent abuse.
- Women who are pregnant, lactating or of childbearing potential and not using an acceptable contraceptive method were also excluded.
Other protocol inclusion/exclusion criteria may apply
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
---|
Proportion of patients free of parasites in the blood after 28 days.
|
次要结果测量
结果测量 |
---|
退烧时间
|
Proportion of patients free of parasites in the blood after 7 days
|
Time to clearance of parasites in the blood
|
Proportion of patients with presence of sexual forms of the parasite in the blood (gametocytes);
|
Hematology and biochemistry
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2001年5月1日
初级完成 (实际的)
2005年8月1日
研究完成 (实际的)
2005年8月1日
研究注册日期
首次提交
2005年10月4日
首先提交符合 QC 标准的
2005年10月4日
首次发布 (估计)
2005年10月5日
研究记录更新
最后更新发布 (估计)
2012年4月27日
上次提交的符合 QC 标准的更新
2012年4月25日
最后验证
2012年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Acute Uncomplicated P. Falciparum Malaria的临床试验
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Universidad Nacional de ColombiaSanofi Pasteur, a Sanofi Company完全的
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Centers for Disease Control and Prevention完全的
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University of OxfordNanyang Technological University; Texas Biomedical Research Institute完全的
Co-artemether的临床试验
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London School of Hygiene and Tropical MedicineUniversity Medical Center Nijmegen; Centre national de recherche et de formation sur le paludisme完全的
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George Papanicolaou Hospital尚未招聘冠状动脉疾病 | 主动脉瓣疾病 | 二尖瓣疾病
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The Cleveland ClinicStryker Orthopaedics完全的
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Medicines for Malaria VentureNucleus Network Ltd; Southern Star Research Pty Ltd.完全的
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Chang Gung Memorial Hospital未知糖尿病 | 外周动脉闭塞症
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Tomsk National Research Medical Center of the Russian...Uppsala University邀请报名
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University of MinnesotaNational Institutes of Health (NIH); National Center for Research Resources (NCRR); Dystonia Medical...完全的