Overview

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.