drugset / Trial / NCT00331136
Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Phase 2
Completed
60 enrolled
Medicines for Malaria Venture
Institute of Tropical Medicine, University of Tuebingen · collabShin Poong Pharmaceuticals · collab
Non-randomizedFactorialOpen-labelTreatment
Summary
The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.
Timeline
- Start
- 2006-06
- Primary completion
- 2006-12
- Completion
- 2006-12
Publications
- Background Ringwald P, Bickii J, Basco L. Randomised trial of pyronaridine versus chloroquine for acute uncomplicated falciparum malaria in Africa. Lancet. 1996 Jan 6;347(8993):24-8. doi: 10.1016/s0140-6736(96)91558-5.
- Ramharter M, Djimde AA, Borghini-Fuhrer I, Miller R, Shin J, Aspinall A, Richardson N, Wibberg M, Fleckenstein L, Arbe-Barnes S, Duparc S. Safety and efficacy of pyronaridine-artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study. Malar J. 2024 Feb 28;23(1):61. doi: 10.1186/s12936-024-04885-3.
- Ayyoub A, Methaneethorn J, Ramharter M, Djimde AA, Tekete M, Duparc S, Borghini-Fuhrer I, Shin JS, Fleckenstein L. Population Pharmacokinetics of Pyronaridine in Pediatric Malaria Patients. Antimicrob Agents Chemother. 2015 Dec 14;60(3):1450-8. doi: 10.1128/AAC.02004-15.
- Duparc S, Borghini-Fuhrer I, Craft CJ, Arbe-Barnes S, Miller RM, Shin CS, Fleckenstein L. Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials. Malar J. 2013 Feb 21;12:70. doi: 10.1186/1475-2875-12-70.
- Ramharter M, Kurth F, Schreier AC, Nemeth J, Glasenapp Iv, Belard S, Schlie M, Kammer J, Koumba PK, Cisse B, Mordmuller B, Lell B, Issifou S, Oeuvray C, Fleckenstein L, Kremsner PG. Fixed-dose pyronaridine-artesunate combination for treatment of uncomplicated falciparum malaria in pediatric patients in Gabon. J Infect Dis. 2008 Sep 15;198(6):911-9. doi: 10.1086/591096.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 2 mg/kg | Oral |
| Subject | Artesunate | Small molecule | 3 mg/kg | Oral |
| Subject | Artesunate | Small molecule | 4 mg/kg | Oral |
| Subject | Pyronaridine | Unknown | 6 mg/kg | Oral |
| Subject | Pyronaridine | Unknown | 9 mg/kg | Oral |
| Subject | Pyronaridine | Unknown | 12 mg/kg | Oral |