Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

• NCT number: NCT00540410
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: September 2007
• Completion date: February 2009