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临床试验/NCT01907672
NCT01907672已完成4 期

The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial

Ghana Health Services2 个研究点 分布在 1 个国家目标入组 4,748 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
4,748
试验地点
2
主要终点
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms

研究概览

简要总结

This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.

详细描述

In many settings the majority of people with malaria particularly the poorest do not access formal care but access anti-malarials at the informal community level. ACTs were previously unaffordable to this group but this should change with the introduction of the AMFm. To avoid missing alternative causes of illness, reduce costs and delay the spread of resistance to ACTs, they need to be targeted at those who really need them. Studies in formal healthcare settings in Ghana have shown that where microscopy is not available, the impact of Rapid Diagnostic Tests (RDTs) can be substantial. RDTs are relatively simple to use, requiring fairly minimal training to master the mechanics of test preparation and interpretation Whether to deploy RDTs as part of AMFm is unclear at this time.Even in the absence of AMFm the question about how best to target antimalarials in the community is an important one, and will get more so as malaria incidence in many countries decreases, making presumptive treatment of all febrile illness as malaria increasingly ineffective. Locally chemical sellers are the closest equivalent as they provide the majority of treatments, especially for the poorest.

It is difficult to predict whether RDTs would make chemical sellers more commonly accessed (because patients prefer a diagnosis) , or less accessed (patients do not like having choice restricted/do not want a blood test etc). Studies in other settings suggest interventions to improve diagnosis by shop-keepers can be effective and cost-effective .

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
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients reporting to chemical seller with complaint of fever or who request for an anti-malarial drug

排除标准

  • Clients providing a prescription from a health facility
  • Clients with signs of severe disease who will be referred onward

结局指标

主要结局

The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms

时间窗: Until the estimated sample size is obtained or up to 2 yrs whichever comes first

Out of all clients who test negative when their blood slides are read by two independent expert microscopists, how many received an antimalarial treatment from the Licensed Chemical Seller

次要结局

  • Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm(Until the estimated sample size is obtained or up to 2 years, whichever comes first)
  • Proportion of clients tested using a Rapid Diagnostic Test(Until the estimated sample size is obtained or up to 2 years, whichever comes first)
  • Proportion of clients in each arm receiving an antibiotic(Until the estimated sample size is obtained or up to 2 years, whichever comes first)
  • Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are(Until the estimated sample size is obtained or up to 2 years, whichever comes first)

研究者

发起方
Ghana Health Services
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Evelyn K. Ansah

Deputy Director (Research)

Ghana Health Services

研究点 (2)

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