Evaluation de l'utilité et du coût-efficacité du Test Rapide Paracheck® Pour la Prise en Charge Des Cas de Paludisme Dans Les régions Des Hauts Bassins et Des Cascades, au Burkina Faso
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- Clearance of fever
研究概览
简要总结
There is increasing evidence from African countries, including Burkina Faso, that at least in some settings/seasons the proportion of fevers attributable to malaria is low or very low: this means that the current strategy of treating all fever cases as malaria is only to the advantage of very few. Rapid, antigenic tests might be of help, particularly in peripheral health centres such as the "Centres de Santé et Promotion Sociale" (CSPS) that lack any laboratory facilities. Nevertheless two major problems could arise:
- False negatives: as only the negative result would change the decision to treat, versus the current "presumptive" strategy, false negatives would not be treated for malaria.
- False positives: they would be exposed to the risk to be left without treatment for the true cause of their fever instead.
The main purpose of this study is to assess if the short term outcome of febrile patients treated after testing with the Rapid Diagnostic Test Paracheck® is at least equivalent (not inferior) to that of controls (presumptively treated without any test) in terms of clearance of fever and other major symptoms and signs.
To do so, febrile patients will be randomly assigned to be submitted to the test before clinical decision, or to be managed the usual way with no test. A follow up will be carried out at Day 4th in order to determine the proportion of patients in both groups with persistence of fever and other main clinical symptoms.
详细描述
Primary outcome: proportion of cases (fever patients randomised to be submitted to the rapid test before treatment) and controls (fever patients randomised not to be submitted to the rapid test) with persisting fever at follow-up.
Secondary outcomes:
- proportion of cases (fever patients randomised to be submitted to the rapid test before treatment) and controls (fever patients randomised not to be submitted to the rapid test) with persisting/new major clinical symptoms/signs and/or clinical complications at follow-up;
- proportion of cases and controls referred to hospital;
- prevalence of malaria infection among febrile and not febrile patients;
- attributable fraction (AF) of fever episodes to malaria infection (as established by subsequent microscopic examination of blood slide and determination of the parasitemia level);
- optimal cut-off level of parasitemia(treatment threshold) in order to define a case of malaria disease vs. a simple malaria infection (i.e., presence of malaria parasites in the blood but presumably not the cause of fever);
- performances of Paracheck® (sensitivity, specificity and predictive values) on malaria disease in the field, compared with expert reading;
- proportion of cases and controls with malaria disease that have not been treated with antimalarials/have been treated for other presumed causes of fever;
- proportion of cases and controls without malaria disease that have been treated with antimalarials/ have not been treated for other presumed causes of fever;
- proportion of cases and control receiving any other treatment, at enrolment and/or at follow up.
Cost - effectiveness models will take into account all costs involved in diagnosis and treatment both for malaria and other conditions.
Sample size. Sample size is determined for the main clinical outcome under study, that is, fever clearance. Expected freq of fever persistence at day 4th: 40 %; maximal accepted difference 10%; power of study 90%; alpha error 5%: sample size 814. We plan to enrol at least 500 subjects with fever per arm in both seasons, in order to account for loss to follow up.
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
- 否
入选标准
- •All patients > 6 months presenting to clinical consultation and consenting to participate/with parental consent to participate.
排除标准
- •Refusal to participate.
- •Severe clinical conditions with emergency treatment needed as judged by the clinical officer.
- •Pregnancy NOT an exclusion criterion
结局指标
主要结局
Clearance of fever
次要结局
- Clearance of major clinical symptoms/signs
- Attributable fraction (AF) of fever episodes to malaria
- Performances of Paracheck® (sensitivity, specificity and predictive values) on malaria disease
- Cost-effectiveness of Paracheck® vs. presumptive (clinical) management of fever