Evaluating the Efficacy of Artesunate-mefloquine on the Thai-Myanmar Border and the Relative Roles of Resistance Genetic Markers: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,022
- 试验地点
- 1
- 主要终点
- proportion of patients with clearance of asexual parasitaemia within 7 days of initiation of trial treatment
研究概览
简要总结
This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum species). The review of patients' records and blood samples will be performed for patients treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to December 2013.
详细描述
The objective of this study is to evaluate the Day 42 PCR adjusted cure rate of mefloquine-artesunate (MAS3) in patients with P. falciparum
Study procedure
Clinic and patient records and log books will be reviewed and the following clinical information will be extracted: vital signs especially the temperature, clinical signs and symptoms, blood slide and haematocrit result and findings of physical examination (anaemia, jaundice, liver, spleen etc). As a routine, these data were recorded on the clinic patient record and malaria smear microscopy logbook accordingly (which will be regarded as the source documents in this analysis). These source documents will be reviewed and stored specimen will be analysed after getting the permission from the Director of Shoklo Malaria Research Unit, the University of Oxford Tropical Research Ethical Committee (OxTREC)and the Faculty of Tropical Medicine Ethics Committee (FTMEC). These data will be extracted and transcribed into the case record forms and entered into Microsoft access. During the data extraction, the unique ID will be assigned to each patient whereas the patients' name will neither be entered into database nor disclosed in the analysis process (ie: the data will be anonymised).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any age and sex who received treatment for uncomplicated malaria and followed up between January 2003 to December 2013
- •Symptomatic of malaria infection, i.e. history of fever or tympanic temperature ≥37.5°c
- •Microscopically confirmed asexual stages of P. falciparum ≥ 5/500 WBC (alone or mixed with non- P. falciparum species)
- •Received fully supervised treatment of mefloquine-artesunate
排除标准
- •Pregnant woman
- •P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells Signs or symptoms indicative of severe malaria29
- •Mefloquine treatment within the 60 days preceding the current episode of malaria
- •Splenectomy
- •Patients will be excluded from the efficacy analysis if they didn't finish the 3 days treatment of mefloquine artesunate but still kept in intention-to-treat population.
结局指标
主要结局
proportion of patients with clearance of asexual parasitaemia within 7 days of initiation of trial treatment
时间窗: 42 days
次要结局
- gametocytaemia(42 days)
- haematocrit change(42 days)
- Proportion of aparasitaemic patients(day 3)
- Prevalence and temporal trend of resistance molecular markers(42 days)