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临床试验/NCT01002066
NCT01002066已完成不适用

Rapid Malaria Diagnostic Tests in Fever Patients Attending Primary Health Care Facilities in Zanzibar - Effectiveness as Diagnostic and Surveillance Tool in the New Context of Low Malaria Endemicity

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 3,890 人开始时间: 2010年5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
3,890
试验地点
1
主要终点
Adherence to Rapid diagnostic tests (RDT) result

研究概览

简要总结

The purpose of this study is to study the effectiveness of wide scale RDT use at the primary health care level in previously high malaria endemic area during malaria pre-elimination phase for improved targeting of anti-malarial drugs, malaria surveillance and epidemic alertness.

详细描述

During the last 6 years Zanzibar has undergone a dramatic change in malaria epidemiology and burden of disease, with a marked decline of Plasmodium falciparum malaria among febrile children from approximately 30% to 1% or below and a reduction of crude child mortality of 50% Overuse of the expensive ACTs will not only be a substantial financial burden on the health care system in Zanzibar, but will also spur anti-malarial drug resistance with devastating effect on global malaria control efforts and prevent other causes of fever from being appropriately treated, e.g. pneumonias which require antibiotics. Rapid Diagnostic Tests (RDTs), based on antigen detection of P. falciparum, are proposed as a future cornerstone to improve diagnostic efficiency also at the peripheral health care level beyond the reach of microscopy services

IMCI algorithms based on clinical symptoms could potentially be made more efficient and cost effective if simple parasitological diagnostic methodologies were incorporated. Zanzibar is among the first regions to incorporate RDT in the IMCI guidelines in Africa, which provides a unique research opportunity to scientifically evaluate the effectiveness of incorporating RDT in the existing IMCI algorithm.

Another key challenge for Zanzibar is to monitor potential development of parasite resistance to ACT when the number of malaria positive patients is insufficient to conduct standard in vivo efficacy trials. We propose that RDT could play a critical new role also in this regard.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

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

入选标准

  • All patients >2 months of age with confirmed fever, with a measured axillary temperature of ≥37.5˚C, or history of fever within the preceding 24 hours
  • Presenting to the health facility from 8.00 to 16.00 Monday to Friday.
  • Informed consent

排除标准

  • Previous enrolment in the study within the last 28 days.
  • Severe disease that requires immediate referral as defined by the clinician

结局指标

主要结局

Adherence to Rapid diagnostic tests (RDT) result

时间窗: Five months

次要结局

未报告次要终点

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Björkman

Professor

Karolinska University Hospital

研究点 (1)

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