drugset / Trial / NCT00529867
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya
Timeline
- Start
- 2007-05
- Primary completion
- 2007-12
- Completion
- 2007-12
Publications
- Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.
- Juma EA, Obonyo CO, Akhwale WS, Ogutu BR. A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya. Malar J. 2008 Dec 22;7:262. doi: 10.1186/1475-2875-7-262.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether | Small molecule | 20 mg | Oral |
| Comparator | Artemether | Small molecule | 21 mg | Oral |
| Comparator | Artemether | Small molecule | 30 mg | Oral |
| Comparator | Artemether | Small molecule | 40 mg | Oral |
| Comparator | Artemether | Small molecule | 42 mg | Oral |
| Comparator | Artemether | Small molecule | 51 mg | Oral |
| Comparator | Artemether | Small molecule | 60 mg | Oral |
| Comparator | Artemether | Small molecule | 72 mg | Oral |
| Comparator | Artemether | Small molecule | 81 mg | Oral |
| Comparator | Artemether | Small molecule | 90 mg | Oral |
| Comparator | lumefantrine | Small molecule | 120 mg | Oral |
| Comparator | lumefantrine | Small molecule | 126 mg | Oral |
| Comparator | lumefantrine | Small molecule | 180 mg | Oral |
| Comparator | lumefantrine | Small molecule | 240 mg | Oral |
| Comparator | lumefantrine | Small molecule | 252 mg | Oral |
| Comparator | lumefantrine | Small molecule | 306 mg | Oral |
| Comparator | lumefantrine | Small molecule | 360 mg | Oral |
| Comparator | lumefantrine | Small molecule | 432 mg | Oral |
| Comparator | lumefantrine | Small molecule | 486 mg | Oral |
| Comparator | lumefantrine | Small molecule | 540 mg | Oral |