Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Adequate clinical and parasitolgical response (ACPR) until D 28
研究概览
简要总结
Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District, north-western Burkina Faso
Phase: Phase II
Objectives: The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity.
Population: Male adults with uncomplicated malaria from Nouna town.
Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB).
Treatment: The participants in the three different MB regimens will receive orally twice daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the five (three) day regimen will only start after all patients of the seven (five) days regimen have been followed up until day 3.
Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR) rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake until day 28, clinical and parasitological failure rates on day 14 and 28, changes in haemoglobin/haematocrit until day 28, and fever and parasite clearance time.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male adults (>17 years;<55 years)
- •Uncomplicated malaria caused by P. falciparum
- •Asexual parasites ≥ 1000/µl and ≤ 200 000/µl
- •Axillary temperatures ≥ 37.5°C or history of fever during 48 hours
- •Living in nouna Health District
- •Informed consent
排除标准
- •Complicated or severe malaria
- •Any apparent significant disease
- •Anaemia (haematocrit < 21%)
- •Antimalarial treatment prior to inclusion (last three days)
- •Increased creatinine blood levels
研究组 & 干预措施
MB3
3 days
干预措施: Methylenblue (Drug)
MB5
5 days
干预措施: Methylenblue (Drug)
MB7
干预措施: Methylenblue (Drug)
结局指标
主要结局
Adequate clinical and parasitolgical response (ACPR) until D 28
次要结局
- Early treatment failure (ETF) rate
- Late clinical failure (LCF) rate at D14 and D28
- Late parasitological failure (LPF) rate at D14 and D28
- Fever clearance time
- Parasite clearance time
- Change in haematocrit after 2,3,7,14 and 28 days compared to baseline
- Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
- Incidence of serious adverse events over the 28 days observation period
- MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose