Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria

Inclusion criteria

• Adults and children ≥ 20 kg
• Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever >37.5°c.
• Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
• Capability of taking an oral medication
• Written informed consent given to participate in the trial
• Willingness and ability to adhere to follow-up visit schedule

Exclusion criteria

• Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age, that is 18 to 45 y/o)
• Female aged 12-18y
• Parasitemia > 150 000/µL).
• Signs or symptoms indicative of severe malaria:

• Impaired consciousness (Blantyre Coma Score <5)
• Severe anaemia (Hct<15%)
• Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites
• Respiratory distress
• Severe jaundice
• Known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or to pyronaridine
• History of splenectomy
• Known history or evidence of clinically significant disorders, such as:

• Known active Hepatitis A, e.g. by detection of anti HAV-IgM.
• Known hepatitis B surface antigen (HBsAg) carrier.
• Known hepatitis C antibody (HCV Ab).
• Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range.