drugset / Trial / NCT01023399
Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later. The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine
Timeline
- Start
- 2009-11
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 25 mg | Oral |
| Subject | Artesunate | Small molecule | 50 mg | Oral |
| Subject | Artesunate | Small molecule | 100 mg | Oral |
| Subject | amodiaquine | Other / unclassified | 67.5 mg | Oral |
| Subject | amodiaquine | Other / unclassified | 135 mg | Oral |
| Subject | amodiaquine | Other / unclassified | 270 mg | Oral |