Evaluation of the Efficacy and Effectiveness of Combined Therapy With Mefloquine and Artesunate for Uncomplicated Malaria Treatment in the Loreto Region (Amazon Basin), Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
研究概览
简要总结
This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 1 year
- •Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause
- •Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear
- •An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)
- •Willingness to come to the health facility for the following 28 days
排除标准
- •Signs or symptoms of severe malaria
- •Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)
- •History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin
- •Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.