NCT00378625已完成3 期
Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia
Centro Internacional de Entrenamiento e Investigaciones Médicas2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2000年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- treatment failures
研究概览
简要总结
The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of:
- Efficacy
- Tolerability
- Time of fever clearance
- Time of parasite clearance
- Proportion of gametocyte carriers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pure P. falciparum infection
- •parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL)
- •age between 1 and 65 years old
- •availability to return for follow-up
排除标准
- •history of allergy to the study drugs
- •history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
- •have a medical history of untreated hypertension or chronic heart, kidney or liver disease
- •present any danger signs of severe malaria.
结局指标
主要结局
treatment failures
adverse events
gametocyte carriage
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in ZanzibarPlasmodium Falciparum MalariaNCT03773536Professor Anders Björkman146
撤回
4 期
Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010Malaria, FalciparumMalnutritionChildNCT01204411Epicentre
已完成
4 期
Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum MalariaMalariaNCT00425763Centers for Disease Control and Prevention110
已完成
4 期
Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Uncomplicated Malaria in South Kivu, DR CongoMalariaNCT02741024Medecins Sans Frontieres, Netherlands288
已完成
2 期
Phase II Artesunate Study in Severe MalariaMalariaNCT00522132Medicines for Malaria Venture200