Feasibility of Methylene Blue-based Combination Therapy in the Radical Treatment of Adult Patients With Plasmodium Vivax Malaria in Ethiopia: a Randomised Controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Study feasibility
研究概览
简要总结
Feasibility of methylene blue-based combination therapy in the radical treatment of adult patients with Plasmodium vivax malaria in Ethiopia: a randomised controlled pilot trial
Study rationale:
Elimination has become the goal of malaria programmes in an increasing number of endemic countries and regions. Primaquine (PQ) is the only registered drug for radical cure of Plasmodium vivax malaria. Prolonged PQ-based combination therapy carries safety concerns and resistance to chloroquine (CQ) and PQ is emerging. Methylene blue (MB) has recently been shown to be safe and effective in the treatment of Plasmodium falciparum malaria in West Africa. As there is evidence for MB probably being effective against the hypnozoites of Plasmodium vivax, MB-based drug regimens could be an alternative to PQ-based combination therapy in Plasmodium vivax malaria.
Study objectives:
The main objective of this trial is to study the feasibility of MB-based combination therapy in patients with uncomplicated P. vivax malaria in an endemic area of Ethiopia.
详细描述
The specific aims are (1) to test the feasibility and costs of methods and procedures for later use of MB-based combination therapy on a large scale, (2) to assess the safety of MB-based combination therapy, (3) to estimate the efficacy of MB-based combination therapy against malaria relapse, (4) to study the community acceptance of MB-based combination therapy, and (5) to strengthen the local capacity for malaria research and control in Jimma/Ethiopia.
Study design:
The study is designed as a pilot trial in adult patients with uncomplicated P. vivax malaria in Jimma, Ethiopia. Patients will be randomised to three treatment groups:
- Arthemeter/Lumefantrine (AL)
- AL-PQ, and
- AL-MB. Follow-up will be over a period of 6 months.
Study population:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Uncomplicated P. vivax monoinfection (asexual parasite count >250/µl)
- •Axillary temperature ≥ 37.5°C or history of fever during last 48 hours
- •Ability to tolerate oral drug therapy
- •Written informed consent of patient
- •Permanent residence in the study area
排除标准
- •Therapy with an antimalarial (e.g. CQ, amodiaquine, pyrimethamine-sulfadoxine, quinine, any ACT) or an antibiotic which is effective against malaria parasites (e.g. doxycyclin, clindamycin, CoTrim) during last three weeks
- •Mixed malaria infection
- •Clinical danger signals (e.g. unable to stand or to sit, unable to drink, repeated vomiting, convulsions) or signs and symptoms of severe malaria (according to WHO definition)
- •Known other serious illnesses (e.g. cardiac, renal, hepatic, pulmonary disease, severe malnutrition, severe infectious diseases)
- •G6PD deficiency (<60% activity, WHO classification 1-3)
- •Patients with known allergy to one or more of the study drugs
- •Hemoglobin value <7 g/dL
- •Pregnancy or breastfeeding
研究组 & 干预措施
Artemeter-Lumefantrine (combination therapy)
33 patients
(standard of care)
干预措施: Artemeter-Lumefantrine (combination therapy) (Drug)
Artemeter-Lumefantrine and Primaquine (combination therapy)
33 patients
干预措施: Artemeter-Lumefantrine and Primaquine (combination therapy) (Drug)
Artemeter-Lumefantrine and MB (combination therapy)
33 patients
干预措施: Artemeter-Lumefantrine and MB (combination therapy) (Drug)
结局指标
主要结局
Study feasibility
时间窗: 180 days
Patient recruitment rates
次要结局
- Study costs(180 days)
- Incidence of P. vivax(180 days)
- Adverse events (AE) during total follow-up period(180 days)
研究者
Olaf Mueller
Prof. Dr.
Heidelberg University