Efficacy of Artemether-lumefantrine, Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malawi

Launched by CENTERS FOR DISEASE CONTROL AND PREVENTION · Mar 30, 2011

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Eligibility criteria

• Inclusion Criteria:
• • age between 6 to 59 months;
• • mono-infection with P. falciparum detected by microscopy;
• • parasitaemia of 2,000-200,000/µl asexual forms;
• • presence of axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C or history of fever during the past 24 h;
• • ability to swallow oral medication;
• • ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
• • informed consent from the parent or guardian of the child.
• Exclusion Criteria:
• • presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
• • mixed or mono-infection with another Plasmodium species detected by microscopy;
• • presence of severe malnutrition (defined as a child whose growth stand¬ard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm) and calculated using EpiInfo 2002 EpiNut calculator;
• • presence of febrile conditions 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 and hepatic diseases, HIV/AIDS);
• • regular medication, which may interfere with antimalarial pharmacokinetics;
• • history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).