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临床试验/NCT00565071
NCT00565071Unknown不适用

Parasite-based Diagnosis for Malaria in Uganda: Feasibility and Cost-Effectiveness

Makerere University1 个研究点 分布在 1 个国家目标入组 102,087 人开始时间: 2006年10月最近更新:
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试验速览

阶段
不适用
入组人数
102,087
试验地点
1
主要终点
diagnostic test validity; unit cost per malaria case diagnosed and treated with Artemether-Lumefantrine; total savings associated with treatment of confirmed malaria cases; compliance with directives for use of rapid test or microscopy

研究概览

简要总结

The purpose of this study is to compare the cost-effectiveness of treating malaria based on three methods of diagnosis (rapid test, microscopy and presumptive diagnosis) among patients attending level three government health centres located in areas of low and high transmission intensities in Uganda. The study hypotheses are: in both low and high transmission areas, cost-effectiveness of malaria treatment with Artemether-Lumefantrine will be improved by the adoption of rapid diagnostic tests when compared with presumptive diagnosis or microscopy; and the difference between the cost-effectiveness of Artemether-Lumefantrine treatment following rapid diagnostic test or microscopy versus presumptive diagnosis will be greatest in low transmission areas.

详细描述

The development of drug resistance in malaria parasites lead the Uganda Ministry of Health (MoH) to change the first-line anti-malarial treatment from the cheap Chloroquine/Sulfadoxine-Pyrimethamine combination to a more expensive Artemether-Lumefantrine. The MoH recommends treatment of all fever cases as malaria within 24 hours of illness with first-line drug. Under this policy, patients who do not have malaria but present with febrile illness will receive Coartem® resulting in significant drug wastage. With the increased cost of first-line drugs, this wastage places a substantial and potentially remediable burden on the health budget. As such, there is a need to gauge whether more accurate malaria diagnosis through microscopy and/or rapid diagnostic tests, might improve the cost-effectiveness of the new treatment regimes.

Specific objectives

  1. To assess the feasibility of rapid test and microscopy in diagnosis of malaria at health centre III.
  2. To compare the cost-effectiveness of treating malaria with Artemether- Lumefantrine based on microscopy, rapid test and presumptive diagnosis in different transmission intensities
  3. To assess whether introduction of malaria parasite-based diagnosis (rapid test or microscopy) at government Health Centre III improves the overall cost-effectiveness of outpatient management of febrile illness

Sample size determination The sample size was determined using standard formula. Estimating the sensitivity of either test to be 90%, Zα =1.96 and after stratifying for age (<5 years and ≥5 years), the calculated sample is 272 per health centre. Therefore, the total number of patients for 6 health centres in two districts = 6 x 272 = 1632.

Baseline: Baseline data was collected on the current malaria treatment practices; clinicians' view of malaria diagnosis; concerns towards the new treatment; and health centre staffing. Geographical locations of all visited government health centres was recorded using Germin etrex global positioning system (Germin International Inc., Olathe, USA). At six selected health centres, social and demographic data was collected from 613 patients.

研究设计

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

入排标准

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

入选标准

  • Suspected uncomplicated malaria infection
  • Consent to participate

排除标准

  • Pregnancy (policy recommends quinine for treatment of malaria in pregnancy)

结局指标

主要结局

diagnostic test validity; unit cost per malaria case diagnosed and treated with Artemether-Lumefantrine; total savings associated with treatment of confirmed malaria cases; compliance with directives for use of rapid test or microscopy

时间窗: 18 months

次要结局

  • unit cost of non-malaria febrile treatment; therapeutic behaviour in light of pressure to prescribe antimalarials(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Institute of Public Health

Prof. Fred Nuwaha, MD, PhD, Makerere University School of Public Health

Makerere University

研究点 (1)

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