Multicentre, open-label randomised clinical trial of efficacy and tolerability of the fixed-dose artesunate/amodiaquine (AS/AQ) combination therapy and amodiaquine (AQ) monotherapy for treatment of uncomplicated falciparum malaria in India

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)0 个研究点目标入组 300 人开始时间: 2008年1月30日最近更新: 2017年4月24日

研究概览

暂无简介。

•1. Children and adults from 6 months to 60 years of age, both genders
•2. For children: body weight greater than 5 kg
•3. Uncomplicated falciparum malaria
•4. Axillary temperature greater than 37.5°C
•5. P. falciparum parasitaemia 1000 - 100,000 asexual forms/µL
•6. Ability to swallow oral medication
•7. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
•8. Written informed consent (participant or parent/guardian)

•1. Presence of general danger signs among the children less than 5 years old or other signs of severe and complicated falciparum malaria according to current World Health Organization (WHO) definitions
•2. Mixed or mono-infection with another Plasmodium species
•3. Presence of severe malnutrition
•4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.) or other known underlying chronic or severe disease (e.g. cardiac, renal, hepatic diseases, human immunodeficiency virus [HIV]/acquired immune deficiency syndrome [AIDS])
•5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
•6. Positive pregnancy test or lactating
•7. H/O antimalarial treatment in past 15 days

发起方

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)