NCT00158561已完成3 期
An Open-label Three Arm Trial of the Efficacy and Safety of Chlorproguanil / Dapsone (Lapdap) Compared With Chloroquine and Sulfadoxine / Pyrimethamine for the Treatment of Vivax Malaria in Pakistan and Afghanistan
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Day 14 slide clearance rate (complete clearance of parasites), assessed by microscopists who are blind to treatment allocation.
研究概览
简要总结
To determine whether two cheap antifolates (chlorproguanil-dapsone and sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are sufficiently effective against vivax malaria to be deployed in areas where diagnosis is poor and the burden of malaria is high, a randomised controlled trial of the three drugs is being undertaken comparing their efficacy in treating malaria.
详细描述
Objectives:
Primary:
To evaluate the comparative efficacy of chlorproguanil / dapsone with sulfadoxine-pyrimethamine for the treatment of vivax malaria in Pakistan and eastern Afghanistan.
Secondary:
- To compare the efficacy of chlorproguanil-dapsone and sulfadoxine-pyrimethamine with chloroquine
- To evaluate the safety profile of chlorproguanil / dapsone in south Asians from this region when used for the treatment of vivax malaria.
- To evaluate the effect of chlorproguanil / dapsone on gametocyte clearance rates.
- To evaluate the effect of chlorproguanil / dapsone on subsequent relapse due to vivax malaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation at BHU or clinic with probable clinical malaria.
- •Infection with P. vivax, confirmed by microscopy.
- •Age 3 years or older (no restriction on upper age limit).
- •Written or witnessed verbal consent obtained from the patient or the patients parent or guardian.
- •Married women of child bearing age confirmed to be non-pregnant at outset and willing to remain thus for the duration of the study.
- •Willingness to comply with the requirements of the protocol and particularly to provide venous and thumb prick blood samples.
- •Available for follow up for the duration of the study and not less than 6 months.
- •Willingness to report to the BHU or clinic if they feel unwell in the 6 months following completion (i.e. 7 months from enrolment date). NB these patients will only be those recruited up to 7 months before the end of the study period.
- •Availability of G6PD status by willingness to be tested at admission.
排除标准
- •General condition requiring hospital admission.
- •Evidence of any concomitant infection likely to mask treatment response at the time of presentation.
- •Presence of any other underlying disease that compromises the diagnosis and the evaluation of the response to the study medication.
- •History of allergy to sulphonamides, dapsone or chloroquine or hypersensitivity to biguanides (eg proguanil, chlorproguanil) sulphones (eg frusemide, thiazides, acetazolamide, and sulphonylureas) or any other tablet contents.
- •Known methaemoglobin reductase deficiency and haemoglobin M.
- •Treatment within the past twenty-eight days with sulfadoxine/pyrimethamine (Fansidar), sulfalene/pyrimethamine (Metakelfin), mefloquine-sulfadoxine-pyrimethamine (Fansimef); 21-days with mefloquine, or 7-days with amodiaquine, chloroquine, halofantrine, quinine (full course), primaquine, atovaquone - proguanil, artemisinin derivatives, co-artemether, trimethoprim, chloramphenicol, erythromycin, tetracycline or clindamycin.
- •Visible jaundice.
- •Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
- •Severe anaemia (Hb<7 g/dl).
- •Other species of malaria seen.
- •Pregnancy, assessed by pregnancy test in all married women of child-bearing age (age over 14 and under 50).
结局指标
主要结局
Day 14 slide clearance rate (complete clearance of parasites), assessed by microscopists who are blind to treatment allocation.
次要结局
- Day 14 clinical failure rate (presence of symptoms of malaria in the presence of parasitaemia).
- Adverse events.
- In G6PD deficient patients the change in mean haemoglobin.
- Day 28 slide clearance rate defined as the number of treated patients with clearance of parasitaemia within 14 days of starting treatment, without subsequent recrudescence up to day 28.
- Number of subsequent malaria episodes in next 6 months. It is assumed that the population of each treatment arm is equally likely to be re-infected in this time scale. Therefore any measurable difference in number of subsequent episodes between treatment
- Day 28 clinical failure rate.
- Clearance of gametocytaemia by day 3, 7, and 14.
- Haemoglobin level increased by at least 1g/dl by day 14.
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine
研究点 (1)
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