Efficacy, Safety and Pharmacokinetic of ArtequinTM P. Falciparum Malaria

Inclusion Criteria: Male or female with a body weight ≥10 to 40 kg Patients suffering from acute uncomplicated Plasmodium falciparum malaria Malaria diagnosis confirmed by a positive blood smear with asexual forms of Plasmodium falciparum (i.e., identification of asexual parasite count ≥1,000 to 250,000 per mm3) Ear temperature 37.5°C or a history of fever within the last 48 hours Haemoglobin 7g/100ml Written informed consent and written consent from parents/guardian for children below age of consent (verbal consent in presence of literate witness is required for illiterate patients or parents/guardians). Exclusion Criteria: Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment (defined according to WHO Recommendations "Malaria Control Today", RBM Working Document, March 2005, see Appendix 2) Patients with known hypersensitivity or allergy to artemisinin derivatives or mefloquine or mefloquine chemically related compounds (for example quinine and quinidine) Patients who had received quinine or any artemisinin derivatives within 12 hours prior to study start Patients who had received any other adequate antimalarial drug therapy including antibiotics which might be active against malaria infection within 1 week prior to study start Patients who had received investigational (unlicensed) drugs as well as mefloquine within 30 days prior to study start Patients with known history of psychiatric disorders Patients with known history of cardiac diseases and arrhythmia Patients with known sickle cell disease Patients with clinical signs of or laboratory evidence for any other severe hepatic, renal, pulmonary, cardiac, metabolic, psychiatric, cancer or haematologic diseases Pregnancy or lactation