Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
- The primary objective of this clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate granule formulation (60:20 mg; paediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate of more than 90%.
- Treatment success or failures will be classified according to WHO Guidelines 2005
|Malaria||Drug: pyronaridine artesunate Drug: arthemeter lumefantrine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Comparative, Open-Labelled, Randomised, Clinical Study to Assess a Fixed Dose of Oral Pyronaridine Artesunate Granule Formulation vs. Coartem® Crushed Tablets in Infants With Acute Uncomplicated Plasmodium Falciparum Malaria|
- PCR corrected ACPR on Day 28 [ Time Frame: Day 28 ]
- PCR-corrected ACPR on Day 14 [ Time Frame: Day 14 ]
- Incidence and severity of adverse events and of cllinically significant laboratory results, ECG, vital signs or physical examination abnormalities [ Time Frame: Day 28 and Day 42 ]
|Study Start Date:||October 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
60mg pyronaridine and 20mg artesunate fixed dose combination granule formulation for 3 consecutive days
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.
Other Name: Pyramax
Active Comparator: 2
120mg lumefantrine and 20mg Artemether fixed dose combination crushed tablets, twice a day for 3 days
Drug: arthemeter lumefantrine
Artemether 20 mg and lumefantrine 120 mg fixed dose combination, 6 dose regimen 120 mg artemether and 720 mg lumefantrine total (Novartis).
The posology is twice daily for 3 consecutive days 1 tablet for patients weighing ≥5 kg to <15 kg, 2 tablets for patients weighing ≥15 to <25 kg.
Other Name: Coartem
The need for safe and efficacious anti-malarial treatments for infants and children is huge given that they are the major group affected by acute uncomplicated malaria. There are relatively few paediatric formulations of artemisinin combination therapies. In addition to the tablet formulation of pyronaridine artesunate (PA) (PYRAMAX), Shin Poong Pharm Co is developing a paediatric dosing form presented as a granule formulation, packed in appropriate aluminium sachets each containing 60mg pyronaridine tetraphosphate and 20mg artesunate.
This Phase III study is designed to demonstrate that the efficacy of PA granule formulation, as assessed in terms of PCR-corrected APCR, is above 90% and subsequently to compare (non-inferiority) the efficacy and safety of PA granule formulation to Coartem® crushed tablets in infants and children.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541385
|Centre National de Recherche et de Formation sur le Paludisme|
|Ouagadougou, Burkina Faso|
|Ecole de Santé Publique, Faculté de Médecine, Université de Kinshasa|
|Kinshasa, DRC, Congo|
|Unité de Paludologie de l'Institut Pasteur d'Abidjan|
|Abdijan, Côte D'Ivoire|
|Medical Research Unit, Albert Schweitzer Hospital|
|Siaya District Hospital, Medical Superintendent's office|
|Siaya Town, Kenya|
|Malaria Research and Training Center, Faculté de Médecine, de Pharmacie et d'Ondonto-stomatologie|
|Instituto Nacional de Saude, Ministero de Saude|
|Puerto Princesa General Hospital|
|Puerto Princesa, Philippines|
|Study Director:||Claude Oeuvray, PhD||Medicines for Malaria Venture|