drugset / Trial / NCT01023399

Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

NCT01023399

Phase 4 Completed 580 enrolled Sanofi Medicines for Malaria Venture · collab
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

EvaluationDrugModalityDoseRoute
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

Indications