Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Medicines for Malaria Venture
• Collaborator: Shin Poong Pharmaceuticals
• Treatments: Artemisinins; Artesunate; Mefloquine; Pyronaridine

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.