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临床试验/NCT00873938
NCT00873938已完成不适用

Compliance to Artesunate-Amodiaquine Therapy for Uncomplicated Malaria in Rural Ghana

Kintampo Health Research Centre, Ghana1 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2005年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
411
试验地点
1
主要终点
The main outcome is compliance to artesunate-amodiaquine combination therapy

研究概览

简要总结

With a change in malaria treatment policy to use combination antimalaria therapy, it is envisaged that compliance to combination therapy would be less than that of monotherapy that was being used for case management in Ghana. This is especially so as amodiaquine is unpopular because of its side-effects and the combination therapy is not a single formulation (fixed dose). Compliance may further be enhanced by community supervision through home visits of combination antimalarial therapy in cases of uncomplicated malaria.

This study would assess compliance to Artesunate-Amodiaquine therapy. It would also assess the effect of compliance to artesunate-amodiaquine therapy on clinical and parasitological cure rates. This study targeting age groups above ten years, would complement a child artesunate -amodiaquine efficacy study being undertaken by the same investigators in children ten years and below at Kintampo District at the same time. The funding for the child study has been approved by the Gates Malaria Partnership. Findings from both studies, involving all age groups would be made available to the National Malaria Control Programme and other stakeholders as practical information that may be beneficial to implementing policy change process from antimalarial monotherapy to a combination therapy.

详细描述

Primary objective:

• To determine compliance to artesunate-amodiaquine therapy among patients diagnosed with acute uncomplicated malaria in the Kintampo District Hospital.

Secondary objectives:

  1. To determine patients compliance to each of the two drugs (artesunate or amodiaquine )
  2. To determine reasons for differential compliance to either of the two drugs (artesunate or amodiaquine).
  3. To determine patients perception and acceptance of artesunate-amodiaquine therapy for acute uncomplicated malaria.
  4. To determine the effect of compliance of artesunate-amodiaquine therapy on clinical and parasitological improvement in acute uncomplicated malaria.

Study design: The study will be a pragmatic randomized control trial. Patients will be recruited based on an inclusion criteria stated below. Baseline clinical symptoms of malaria and presence of malaria parasite (Plasmodium falciparum) in the blood of eligible patients reporting sick at the health facility would be determined. Study patients would be randomized into one of two groups, intervention and control groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The main outcome is compliance to artesunate-amodiaquine combination therapy

时间窗: Within first three days after diagnosis of malaria

次要结局

  • Reasons for non-compliance(Within 28 days after diagnosis of malaria)
  • Participants' perception and acceptance of supervision(Within 28 days after diagnosis of malaria)
  • Parasite clearance rates on day 14 and 28(Within 28 days after diagnosis of malaria)

研究者

发起方
Kintampo Health Research Centre, Ghana
申办方类型
Other

研究点 (1)

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