Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 920
- 试验地点
- 1
- 主要终点
- Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.
研究概览
简要总结
The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.
详细描述
Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. Uganda adopted Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. However, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. This study will assess if AL blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector
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
- 4 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50C.
- •Weight between 5 kg and 25 kg
- •Positive malaria smear results for P. falciparum
- •No history of intake of AL in the preceding two weeks
- •Able to tolerate oral therapy
- •Caregiver has given written informed consent to participate in the study
- •If they reside within the designated catchment area of the health facility
排除标准
- •Features of life threatening illness including severe malaria
研究组 & 干预措施
AL Blister-pack
干预措施: AL Blister-packs with Instruction leaflets (Drug)
AL unit dose age specific pre-packs
干预措施: AL unit dose age specific pre-packs (Drug)
结局指标
主要结局
Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.
时间窗: Day 3
次要结局
- Parasitological cure rates(Day 28)
- Clinical cure rates(Days 3)