Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Centre Muraz
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of treatment failures
研究概览
简要总结
This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.
详细描述
Study background and purpose
- Resistance to usual drugs was widespread and has required a change of the malaria treatment by several countries
- Several countries have changed their first-line treatments to ACTs; mainly AL and ASAQ. & have adopted the use of RDTs prior to treatment
- Indeed, this contributes to decrease the number of unnecessary treatments and thus improve the management of malaria cases.
- In February 2005, Burkina Faso changed its national drug policy from Chloroquine to Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL)
- the country has also implemented the strategy of using the Rapid Diagnosis Tests (RDTs) for the diagnosis of malaria prior to treatment
- Though endemic countries are being encouraged to implement RDTs, choosing a particular RDT is not easy as several brands are available on the market.
- In addition, little information on the performance of RDTs in Africa is available and recently quality problems have been reported with some RDTs.
- In this context, it is important to locally assess the performance of RDTs compared with the microscopy, which is the gold standard for the malaria diagnosis and to assess the efficacy of the new drugs used for malaria treatment
This is a phase IV two-arm randomized open-label study aiming at recruiting 150 patients to assess the efficacy of ASAQ and AL in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the RDT compared to the microscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 6 months,
- •eight above 5 kg;
- •Positive blood slide (parasitaemia ≥ 2,000/μL to 200,000/μL) with Plasmodium falciparum monospecific infection ;
- •Fever (axillary temperature above 37.5 °C) or history of fever in the preceding 24 hours;
- •Haemoglobin value above or equal 5.0 g/dL
- •Signed informed consent;
- •Willingness and ability to comply with the study protocol for the duration of the trial.
排除标准
- •Participation in any other investigational drug study (antimalarial or others) during the previous 30 days
- •Known hypersensitivity to the study drugs
- •Severe malaria
- •Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (more than 1 in 24h), unconscious state, unable to sit or stand;
- •Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study.
- •Severe malnutrition (defined as weight for height less than 70% of the median NCHS/WHO reference)
- •Known pregnancy
研究组 & 干预措施
Amodiaquine-Artesunate
ASAQ is produced by Sanofi-Aventis as CoarsucamTM and as artesunate-amodiaquine Winthrop®
干预措施: Amodiaquine-Artesunate (Drug)
Artemether-Lumefantrine
AL (tablets containing 20 mg of artemether and 120 mg of lumefantrine) is produced by Novartis
干预措施: Artemether-lumefantrine (Drug)
结局指标
主要结局
Rate of treatment failures
时间窗: 28 days
The rate of the two ACTs treatment failures at day 28: all treatment failures, both parasitological and clinical (positive blood slide at day 28)
次要结局
- RDT performance Vs microscopy(28 days)