Artemisinin Resistance in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Cure
研究概览
简要总结
A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.
详细描述
A total number of 100 volunteers with acute uncomplicated falciparum malaria will be randomly assigned one of 3 arms to be treated with artesunate monotherapy or quinine/doxycycline for 7 days at a ratio of 2:2:1. The study design will be based on the WHO recommendations for the 'Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria' (WHO, 2003). Study participants will be otherwise healthy malaria patients aged 8 to 65 years with uncomplicated falciparum malaria recruited at the Bandarban Sadar Hospital, Bangladesh.
The artesunate will be administered orally (a single dose of 2 or 4 mg/kg/day) over a total duration of 7 days by directly observed therapy.
Patients will be admitted to the hospital for the duration of study drug administration or until all signs and symptoms of malaria have disappeared, whichever comes later. Thereafter they will be followed as outpatients until Day 42 with scheduled follow-up visits on Day 14, 28, 35, and 42.
In vitro drug sensitivity assays will be performed from samples on inclusion and in case of recrudescence. Drug levels will be measured on the first and last day of therapy.
Primary clinical outcome is cure (Adequate Clinical and Parasitological Response - ACPR) on Day 28 and 42. Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT). Parasite genotyping will be used to distinguish recrudescences from reinfections by PCR for patients in whom recrudescences cannot be fully excluded. Subjects will be monitored for clinical adverse events throughout the study duration.
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
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute symptomatic falciparum malaria infection as determined by malaria smear with a parasite density of 1,000 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5C), or reported history of fever within the last 48 hours.
- •Age: 8-65 years old
- •All females between the age of 12 and 50 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception throughout the study
- •Written informed consent obtained
- •Willing to stay under close medical supervision for the study duration of 42 days
- •Otherwise healthy outpatients
排除标准
- •Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception
- •Mixed malaria infection on admission by malaria smear
- •A previous history of intolerance or hypersensitivity to the study drugs or to drugs with similar chemical structures
- •Malaria drug therapy administered in the past 30 days by history
- •History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
- •Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
- •Signs or symptoms of severe malaria (as defined by WHO 2000)
- •Unable and/or unlikely to comprehend and/or follow the protocol
研究组 & 干预措施
AS 2mg/kg
Artesunate monotherapy 2mg/kg/day for 7 days
干预措施: Artesunate (Drug)
AS 4mg/kg
Artesunate monotherapy 4mg/kg/day for 7 days
干预措施: Artesunate (Drug)
QD Control
Quinine-doxycycline for 7 days
干预措施: quinine-doxycycline (Drug)
结局指标
主要结局
Cure
时间窗: 42 days
Cure is defined as adequate clinical and parasitological response (ACPR) as opposed to early treatment failure / late treatment failure
次要结局
- Treatment response(42 Days)
研究者
Harald Noedl
Assoc. Prof. Dr.
Medical University of Vienna