Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Pyronaridine - artesunate; Mefloquine plus artesunate
Intervention description: once a day for 3 days; once a day for 3 days
Intervention MeSH terms: Artesunate; Mefloquine; Pyronaridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1271.0
Sex: All
Minimum age: 3 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: malaria; antimalarial; P falciparum; pyronaridine; artesunate; artemisinin based combination therapy (ACT); pyronaridine artesunate (Pyramax)

Summary:

      The primary objective of this phase III clinical study is to compare the efficacy and safety
      of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the
      combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated
      P falciparum malaria in South East Asia, India and Africa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients between the ages 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 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,
             mefloquine or artesunate or other artemisinins.

          -  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.

          -  Presence of significant renal or hepatic impairment.

          -  Receipt of an investigational drug within the past 4 weeks.

          -  Known active Hepatitis A IgM, Hepatitis B surface antigen or Hepatitis C antibody.

          -  Known seropositive HIV antibody.

          -  Previous participation in any clinical study with PA.