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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicines for Malaria Venture
• Collaborator: Shin Poong Pharmaceuticals
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine; Pyronaridine

Criteria

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 a 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] >2.5 times the upper limit of normal range.

• Known significant renal impairment as indicated by serum creatinine >1.4 mg/dL.