Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

535

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

November 30, 2008

Conditions
Malaria
Interventions
DRUG

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.

DRUG

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.

Trial Locations (8)

Unknown

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

All Listed Sponsors
collaborator

Shin Poong Pharmaceuticals

INDUSTRY

lead

Medicines for Malaria Venture

OTHER

NCT00541385 - Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients | Biotech Hunter | Biotech Hunter