Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients

Inclusion Criteria:

• Male or female patients between the age of 3 and 60 years, inclusive.
• Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

• Presence of acute uncomplicated P. falciparum mono-infection confirmed by:

  1. Fever, as defined by axillary/tympanic temperature ≥ 37.5°C or oral/rectal temperature ≥ 38°C, or documented history of fever in the previous 24 hours and,
  2. Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/μl of blood.
• Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse.
• Ability to swallow oral medication.

Exclusion Criteria:

• Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000.
• Mixed Plasmodium infection.
• Severe vomiting or severe diarrhoea.
• Known history or evidence of clinically significant disorders.
• Presence of significant anaemia, as defined by Hb < 8 g/dL.
• Presence of febrile conditions caused by diseases other than malaria
• Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, lumefantrine or artesunate or other artemisinins.
• Patients with known disturbances of electrolytes balance, e.g., hypokalaemia or hypomagnesaemia.
• Use of any other antimalarial agent within 2 weeks prior to start of the study as evidenced by positive urine test.
• Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
• Patients taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (flecainide, metoprol, imipramine, amitriptyline, clomipramine).
• Received an investigational drug within the past 4 weeks.
• Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen. (HBsAg) or Hepatitis C antibody (HCV Ab).
• Known seropositive HIV antibody.
• Liver function tests [ASAT/ALAT levels] more than 2.5 times upper limit of normal range.
• Known significant renal impairment as indicated by serum creatinine of more than 1.4 mg/dL.