A Randomised Trial of Rapid Diagnostic Tests in the Diagnosis of Non-Severe Malaria at Different Transmission Intensities of Plasmodium Falciparum in Tanzania
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 2
研究概览
简要总结
There is clear evidence diagnosis of malaria in much of Africa is sub-optimal and this has a negative impact on patient care. Many of those treated for malaria do not have it. Rapid diagnostic tests (RDTs) are dipsticks which diagnose malaria rapidly and accurately. The main objective of this trial is to determine by means of a randomised trial the impact of introducing RDTs into a standard outpatient setting in Tanzania has on the appropriate prescription of antimalarials. Other objectives are:
- To compare at high, moderate and low P.falciparum transmission intensity the sensitivity and specificity of malaria diagnosis using hospital slide results and RDTs, using research quality slides as the reference.
- To estimate the specificity of clinical diagnosis of malaria at high, moderate and low transmission intensity of P. falciparum.
- To compare the proportion of cases reported as slide-negative who are treated for malaria with the proportion of RDT-negative cases treated for malaria.
- To evaluate the cost effectiveness of introducing RDTs compared to current diagnostic practice in facilities with microscopic diagnosis of malaria at different levels of transmission of P.falciparum.
详细描述
In each of the hospital outpatient facilities, patients consenting to participate will have a free malaria test but the test will be randomly assigned to hospital laboratory blood slide or RDT.
Sensitisation of sites and information displayed.
Before the start of the intervention study we will conduct meetings with the medical staff to explain the intervention and standard study procedure. We will provide information from published sources of the accuracy of 'Paracheck' compared to expert slide reading. Staff will be encouraged to use the RDT result in the same way that they would use a blood slide result of equivalent accuracy. We will consult with the Malaria Control Programme what additional information they would disseminate if they were deploying the tests.
Information will be displayed for patients attending the clinic that, for the period of the trial, malaria diagnosis will be free if requested by the clinic doctor. Patients consenting to participate will be randomly allocated to receive either a slide test or RDT. Patients who do not consent to participate will receive free hospital slide testing if requested by the clinic doctor and their treatment will follow routine practice.
Inclusion criteria
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of any age attending the outpatient facility will be eligible to be considered for the trial
- •A clinician decision to request a malaria test.
排除标准
- •Where a clinician decides that they would prefer a hospital slide to the patient entering the trial- these cases will be noted but excluded from the trial.
- •Patients are admitted from outpatients to the ward Those who appear to the study clinical officer to be too distressed or ill to participate.
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine