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

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