Etude de l'Activite (Efficacite et Tolerance) de l'Association de la Chloroquine Avec la Dehydroepiandrosterone-Sulfate (Dheas) Dans le Traitement de l'Acces Palustre Simple A Plasmodium Falciparum
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Development of any adverse event;
研究概览
简要总结
This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen administration supplemented with dehydroepiandrosterone sulfate against drug-resistant malaria.
详细描述
Worldwide progression of Plasmodium falciparum chloroquine (CQ), amodiaquine and sulfadoxine-pyrimethamine resistance leaves few alternative for the control of malaria, particularly in Africa. For some strains of P. falciparum and P. berghei, the resistance to CQ and AQ is linked to an increase in reduced glutathione (GSH) levels and GSH-related enzyme activity, such as glucose 6-phosphate deshydrogenase (G6PD). The pro-hormone dehydroepiandrosterone sulphate can be used to potentiate the antimalarial action of CQ on drug resistant P. falciparum strains, by inhibiting parasite G6PD activity. This hormone has a second advantage: it is metabolised in human into a series of potent immunomodulatory steroids which may be in the causal pathway that allowed the induction of protective immune responses against several infections, included malaria. This first study evaluated the tolerance and efficacy of a standard CQ regimen supplemented with dehydroepiandrosterone sulphate for the treatment of drug resistant uncomplicated falciparum malaria.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signing an informed consent (informed consent was given by legal guardian for children);
- •age egal or more than 15 years;
- •fever (axillary temperature egal or more than 37.5 °C and less than 40°C) or a history of fever within the last 24 hours;
- •no sign suggestive of other febrile illness;
- •absence of signs of complicated malaria (WHO criteria);
- •willingness to participate in follow-up for 14 days
- •a positive thick blood film for P. falciparum without other detectable infectious microorganisms
排除标准
- •patients taking glucocorticoids or other immuno-suppressive drugs, or indicating recent antimalarial drug history (verbal questionnaire);
- •severe malaria;
- •mixed infections;
- •women using contraceptives;
- •pregnant women;
- •breast-feeding women.
结局指标
主要结局
Development of any adverse event;
Rate of clinical and/or parasitological failure during the 14 days of follow up.
次要结局
- Proportion of patients with positive blood smear during follow-u;
- Mean parasitemia during follow-up;
- Proportion of patients with clinical symptoms on day 3.