Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 3
- 主要终点
- therapeutic and parasitological cure with no recrudescence
研究概览
简要总结
The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.
详细描述
To determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ 40mg/kg) treatment arms and followed for up to 60 days.
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
- None
入排标准
- 年龄范围
- 6 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •slide-confirmed infection with P. falciparum only
- •initial parasite density of 1000-100,000 asexual parasites/μl
- •absence of severe malnutrition
- •ability to attend stipulated follow-up visits and easy access to facility
- •informed consent provided by patient or parent/guardian
- •absence of history of hypersensitivity reactions to CQ
排除标准
- •infants under six months old
- •pregnancy or lactation
- •underlying chronic severe illness
- •patients with other febrile illnesses
- •parasitaemia outside the range of 1000-100,000 asexual parasites/µl
- •severe malaria
研究组 & 干预措施
CQ25
Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.
干预措施: Chloroquine (Drug)
CQ40
Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.
干预措施: Chloroquine (Drug)
结局指标
主要结局
therapeutic and parasitological cure with no recrudescence
时间窗: 60 days
次要结局
- parasite clearance time(28 days)
- fever clearance time(28 days)
- gametocytaemia(28 days)