Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria

Inclusion Criteria: * Male and female subjects aged 1 to 60 years inclusive * Body weight between 5kg and 90kg inclusive * Acute manifestations of a mono-infection with Plasmodium falciparum as determined by either a rapid diagnostic test for adults or microscopically confirmed by an asexual parasitaemia of 1,000 to 150,000/uL and fever with an axillary temperature of \> 37.5 degress C or oral/rectal/tympanic temperature of \> 38.0 degrees C or history of fever during the previous 72 hours * Compliance with contraceptive measures throughout the study period of 63 days in females of child bearing potential Exclusion Criteria: To be eligible for inclusion in the study, subjects must NOT meet any of the following criteria: * Signs of severe/complicated malaria according to WHO criteria * Pregnancy as excluded by negative serum human chorionic gonadotrophin (hCG) test * Lactation * Mixed Plasmodium infection * Severe vomiting on three or more occasions in the previous 24 hours * Severe diarrhoea on four or more occasions in the previous 24 hours * Concomitant disease masking assessment of response including * abnormal liver function tests with bilirubin \> 40 µmol/L, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) levels \> x 2 upper limit of normal * impaired renal function with creatinine level \> x 2 upper limit of normal * haemoglobin level \< 7.5g/dl * white cell count \> 12000/µL * History of cardiovascular disease including arrhythmia with QTc interval ≥ 450msec, respiratory disease including active tuberculosis, hepatic disease including jaundice, renal failure, malignancy, neurological disorders including convulsions and psychiatric disturbances * History of immunological disease including Hepatitis A, B and C and HIV-AIDS * Severe malnutrition * History of hypersensitivity or adverse reactions to fosmidomycin, piperaquine, artesunate and mefloquine * Treatment with antimalarial and antibacterial agents within the previous 28 days