Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 3
- 主要终点
- result of PCR
研究概览
简要总结
This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.
All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.
Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults and children ≥ 20 kg
- •Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever >37.5°c.
- •Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
- •Capability of taking an oral medication
- •Written informed consent given to participate in the trial
- •Willingness and ability to adhere to follow-up visit schedule
排除标准
- •Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age, that is 18 to 45 y/o)
- •Female aged 12-18y
- •Parasitemia > 150 000/µL).
- •Signs or symptoms indicative of severe malaria:
- •Impaired consciousness (Blantyre Coma Score <5)
- •Severe anaemia (Hct<15%)
- •Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites
- •Respiratory distress
- •Severe jaundice
- •Known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or to pyronaridine
- •History of splenectomy
- •Known history or evidence of clinically significant disorders, such as:
- •Known active Hepatitis A, e.g. by detection of anti HAV-IgM.
- •Known hepatitis B surface antigen (HBsAg) carrier.
- •Known hepatitis C antibody (HCV Ab).
- •Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range.
研究组 & 干预措施
Pyronaridine-artesunate
Pyronaridine-artesunate (Pyramax®, Shin Poong Pharmaceuticals). One tablet contains 60mg artesunate+ 180mg pyronaridine. Dosing will be according to body weight.
It will be taken orally with water, once daily for 3 days. Each dose will be administered under the supervision. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only.
20 - < 24 kg = 1 tab 24 - < 45 kg = 2 tabs 45 - < 65 kg = 3 tabs 65 and above = 4 tabs
干预措施: Pyronaridine-artesunate (Drug)
结局指标
主要结局
result of PCR
时间窗: 42 day
次要结局
- eosinophil count(at day 0, 3, 7 and day 28)
- fever clearance time(24 hours)
- PCR uncorrected ACPR(at 28 days or 42 days)
- gametocyte clearance times(at day 0, 3, 7 and day28)
- hepatic biological values(at day 0, 3,7 and day 28)
- K13 and pfmdr1 of P falciparum resistance(at day 0, 3, 7 and day 28)
- numbers of patients with a positive malaria slide 72 hours after treatment initiation(72 hours)
- PCR corrected ACPR(at 28 days and 42 days)
- Number of patient with reinfection and recrudescences(over 42 days)
- Gametocyte carriage rates(at day 0, 3, 7 day 28)