跳至主要内容
临床试验/NCT01115439
NCT01115439已完成不适用

Efficacy and Safety of Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malaria Control Centers in Nangarhar, Kunar, Thakhar and Faryab Provinces of Afghanistan

University of Oxford1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Proportion of patients experiencing therapeutic failure

研究概览

简要总结

In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium falciparum resistance to chloroquine (80%) and more recently an increasing degree of resistance to sulfadoxine-pyrimethamine monotherapy (12%). In 2003 the high failure rate of chloroquine against falciparum malaria led the national malaria treatment programme to switch its recommended first line drug treatment for uncomplicated Plasmodium falciparum malaria to artemisinin-based combination therapy (ACT) in the form of Artesunate/Sulfadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7 days). The aim of this study is to conduct ongoing monitoring of the efficacy of the new combination against P. falciparum in a group of sentinel sites in Afghanistan.

详细描述

The objective of the study is to assess the efficacy and safety of Artesunate/Sulfadoxine-Pyrimethamine (AS+SP) for the treatment of uncomplicated P. falciparum infections in Nangarhar, Kunar, Thakhar, Faryab malaria control centers in Afghanistan.

This is an observational study. Patients will receive the recommended treatment for P. falciparum malaria in Afghanistan (Nangarhar, Kunar, Thakhar, Faryab malaria control centers). The participants will be febrile children above six months of age and non-pregnant adults with confirmed uncomplicated P. falciparum infection. Patients will be treated with AS+SP according to standard dosing regimens. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy. The study will be conducted during the transmission season of falciparum malaria, i.e. October 2009 to January 2010 and September-December, 2010. Patients will be assessed clinically and via laboratory tests, particularly focussing on whether recurrences are recrudescences of the original infection or reinfections. All bio-medical findings will be recorded in specific patient case record forms and the electronic form of analyzed data as well as a final report will be sent to WHO-Afghanistan and National malaria control program offices for further actions. The patients will receive reasonable transportation costs for follow-up visits as well as one insecticide treated bed-net at the end of enrolment. The results of this study will be used to assist the Ministry of Health of Afghanistan in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Months 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

研究组 & 干预措施

falciparum malaria

Febrile children (above six months of age) and non-pregnant adults with confirmed uncomplicated P. falciparum infection

干预措施: artesunate plus sulfadoxine-pyrimethamine (AS+SP) (Drug)

结局指标

主要结局

Proportion of patients experiencing therapeutic failure

时间窗: 42 days

Proportion of patients experiencing therapeutic failure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验