Malaria Clinical Trial
Official title:
A Nested Open Labeled Study to Compare the Effectiveness and Safety of a Fixed-dose Combination of Artesunate Plus Amodiaquine (ASAQ Winthrop®) in the Unsupervised Treatment of Uncomplicated Plasmodium Falciparum Malaria Attacks in Two Patient Groups Enrolled at Two Year-intervals in a Pilot District of Côte d'Ivoire
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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