Malaria Clinical Trial
Official title:
A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal
Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and
parasitological response at D28 of artesunate + amiodaquine versus artemether +
lumefantrine, based on the first malaria attack of each subject.
Secondary objectives:
For the first attack: To compare the two groups of treatment in terms of:
- D14 efficacy
- Parasitological and fever clearance
- Clinical and biological tolerability
- Evolution of gametocyte carriage
- Cardiac tolerability (QTc)
For the repeated attacks: To compare the two groups of treatment in terms of:
- D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
- Clinical and biological tolerability
- Proportion of patients without fever at D3
- Proportion of patients without parasite at D3
- Compliance
- Impact on anaemia
During the total follow-up of the cohort: To compare the two groups of treatment in term of:
- Treatment incidence density
- Impact of repeated treatment on clinical and biological safety
- Impact of repeated treatment on hearing capacity
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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