Phase IIIb/IV Cohort Event Monitoring Study To Evaluate, In Real Life Setting, The Safety And Tolerability In Malaria Patients Of The Fixed-Dose Artemisinin-Based Combination Therapy Pyramax®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8,572
- 试验地点
- 5
- 主要终点
- Evaluation and identification of hepatic safety events, including raised liver function tests
研究概览
简要总结
The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (<1 year of age).
详细描述
This is a non-comparative Cohort Event Monitoring study. The study will assess the safety of Pyramax in terms of the evaluation and identification of the hepatic safety events in a sub group of patients enrolled with liver function tests (LFT)s >2x upper limit of normal (ULN) from blood taken immediately prior to treatment without any clinical signs or symptoms of hepatotoxicity and with signs and symptoms of uncomplicated malaria confirmed by a Rapid Diagnostic Test (RDT) or microscopy (thick blood smear). The study will compare the clinical hepatic safety of Pyramax between a cohort of patients enrolled with LFTs >2xULN and a cohort of patients enrolled with normal LFTs matched for demographic characteristics.
An estimated 8,572 malaria episodes are to be recruited to provide 120 malaria episodes in patients with baseline raised LFTs >2xULN for follow up of liver function. A cohort of at least 2% of children who are <1 year of age will be included for monitoring of liver function.
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
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations:
- •Fever or history of fever in the previous 24 h and/or the presence of anaemia, for which pallor of the palms appears to be the most reliable sign in young children.
- •Confirmation of malaria by a parasitological diagnosis (RDT or Microscopy (thick blood smear). analysis).
- •Weight ≥5 kg - < 20 kg (granules); ≥20 kg (tablets).
- •Ability to take an oral medication.
- •Ability and willingness to participate based on signed informed consent (a parent or a guardian has to sign for children below 18 years old) and on signed assent form for minors that could be required per national regulations in each participating country.
- •The patient has to comply with all scheduled follow-up visits.
排除标准
- •Patients with clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage 3 or 4).
- •Known allergy to artemisinin and/or to pyronaridine.
- •Known pregnancy.
- •Lactating women should be excluded if other anti-malarial treatments are available.
- •Complicated malaria as per WHO definition (Annex 2)
- •Patients that the investigator considers would be at particular risk if receiving an anti-malarial or if participating in the study.
- •Patients having been treated with Pyramax in the previous 28 days.
研究组 & 干预措施
Pyramax
Pyronaridine artesunate tablets (180/60mg) and granules (60/20mg)
干预措施: pyronaridine artesunate (Drug)
结局指标
主要结局
Evaluation and identification of hepatic safety events, including raised liver function tests
时间窗: Assessment up to Day 28.
Evaluation and identification of hepatic safety events (including raised liver function tests - LFTs) of Pyramax in a sub group of malaria patients enrolled with LFTs \>2xUL.
次要结局
- Overall safety(Assessment up to Day 28.)
- Evaluation of Efficacy(Assessment up to Day 28.)