Status:
COMPLETED
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
Lead Sponsor:
Medicines for Malaria Venture
Collaborating Sponsors:
Shin Poong Pharmaceuticals
Conditions:
Malaria
Eligibility:
All Genders
3-60 years
Phase:
PHASE3
Brief 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, A...
Detailed Description
This is a multi-centre, comparative, randomised, (double-blind, double-dummy), parallel-group, non-inferiority study comparing the efficacy and safety of the fixed combination of PA with that of AL in...
Eligibility Criteria
Inclusion
- 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:
- 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,
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
1272 Patients enrolled
Trial Details
Trial ID
NCT00422084
Start Date
January 1 2007
End Date
May 1 2008
Last Update
November 2 2021
Active Locations (10)
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1
Ecole de Santé Publique, Faculté de Médecine, Université de Kinshasa
Kinshasa, Democratic Republic of the Congo
2
Komfo Anoykye Teaching Hospital
Kumasi, Ghana
3
RSUD TC Hillers
Maumere, Nusa Tenggara Timur, Indonesia, 86113
4
Jayapura General Hospital (RSUD) DOK II
Jayapura, Special Region of Papua, Indonesia