A randomised study to assess the efficacy and tolerability of three Artemisinin-based combination therapy (ACT) in The Democratic Republic of Congo (DRC)

The Centre for Tropical Medicine (UK)0 个研究点目标入组 684 人开始时间: 2011年10月6日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Children aged 3 to 59 months
•2. Weight = 5 kg [the minimum weight for treatment with artemether-lumefantrine (ALN)]
•3. Mono-infection with P. falciparum
•4. Parasitaemia of =2,000 and =200,000 asexual parasites per µL
•5. Axillary temperature 37.5 °C or history of fever in the preceding 24 hrs
•6. Ability to swallow oral medication
•7. Haemoglobin =5.0 g/dL
•8. Parents/guardians agree to hospitalize the child for the length of treatment (34 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
•9. Signed consent from guardian / parents

•1. Danger signs of severe malaria or signs of severe malaria (WHO 2000)
•2. Children with severe malnutrition, marasmus or oedematous malnutrition (WHO 2006)
•3. Febrile condition due to diseases other than malaria [e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, human immunodeficiency virus (HIV) / acquired immune deficiency syndrome (AIDS)]
•4. History of hypersensitivity reactions or contraindication to any medicine being tested
•5. A clear history of adequate antimalarial treatment in the preceding 72 hours with drugs expected to be effective
•6. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV positive women

发起方

The Centre for Tropical Medicine (UK)