Status:
COMPLETED
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
Lead Sponsor:
Medicines for Malaria Venture
Collaborating Sponsors:
Shin Poong Pharmaceuticals
Conditions:
Falciparum Malaria
Eligibility:
All Genders
3-60 years
Phase:
PHASE3
Brief 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 mefloqui...
Detailed Description
This is a multi-centre, comparative, randomised, open-label, parallel-group, non-inferiority study comparing the efficacy and safety of a fixed combination of PA to a loose combination of MQ + AS for ...
Eligibility Criteria
Inclusion
- 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:
- 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 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, 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1271 Patients enrolled
Trial Details
Trial ID
NCT00403260
Start Date
January 1 2007
End Date
December 1 2008
Last Update
November 2 2021
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
RAOTAP2/Centre Muraz
Bobo-Dioulasso, Houet Province, Burkina Faso, 01 BP390
2
Pailin Referral Hospital
Pailin, Pailin, Cambodia
3
Institut Pasteur
Abidjan, Côte d’Ivoire
4
Wentlock District Hospital
Mangalore, India