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临床试验/NCT01194557
NCT01194557已完成不适用

Introducing Rapid Diagnostic Tests Into the Private Health Sector in Uganda: a Randomised Trial Among Registered Drug Shops to Evaluate Impact on Antimalarial Drug Use

DBL -Institute for Health Research and Development1 个研究点 分布在 1 个国家目标入组 2,600 人开始时间: 2010年9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
发起方
入组人数
2,600
试验地点
1
主要终点
Appropriateness of treatment

研究概览

简要总结

Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.

This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug shops in an area with high malaria transmission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients with fever
  • uncomplicted malaria

排除标准

  • Complicated malaria
  • known allergic reactions to Lumartem

研究组 & 干预措施

rapid diagnostic test

Active Comparator

Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests

干预措施: Rapid diagnostic test (Device)

rapid diagnostic test

Active Comparator

Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests

干预措施: Lumartem (Drug)

结局指标

主要结局

Appropriateness of treatment

时间窗: 36 months

次要结局

  • Appropriateness of referral of complicated malaria cases(36 months)

研究者

发起方
DBL -Institute for Health Research and Development
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pascal Magnussen

Senior Researcher

DBL -Institute for Health Research and Development

研究点 (1)

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