535
Participants
Start Date
October 31, 2007
Primary Completion Date
September 30, 2008
Study Completion Date
November 30, 2008
pyronaridine artesunate
The strength of the granule formulation is 60:20 mg pyronaridine artesunate per sachet. Depending on their body weight, patients will receive between 1 to 3 pyronaridine artesunate sachets per day, for 3 consecutive days The actual dose-range covered by this regimen is 7.0:2.3 mg/kg to 13.3:4.4 mg/kg pyronaridine artesunate, which has shown to be effective and safe in the phase II studies conducted in children and adults.
arthemeter lumefantrine
The strength of the tablet is 20 mg artemether and 120 mg lumefantrine. Depending on their body weight, patients will receive either 1 or 2 crushed tablets twice a day (≥5 to \<15 = 1 tablet, 15 to \<25 kg = 2 tablets), for 3 consecutive days.
Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou
Unité de Paludologie de l'Institut Pasteur d'Abidjan, Abidjan
Ecole de Santé Publique, Faculté de Médecine, Université de Kinshasa, Kinshasa
Medical Research Unit, Albert Schweitzer Hospital, Lambaréné
Siaya District Hospital, Medical Superintendent's office, Siaya
Malaria Research and Training Center, Faculté de Médecine, de Pharmacie et d'Ondonto-stomatologie, Bamako
Instituto Nacional de Saude, Ministero de Saude, Maputo
Puerto Princesa General Hospital, Puerto Princesa City
Shin Poong Pharmaceuticals
INDUSTRY
Medicines for Malaria Venture
OTHER