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Coarsucam®

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

Ensayo de Sanofi en Malaria (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

366

previstos

Centros

1

Fin del objetivo primario

feb 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2007.

Qué mide

PCR corrected and uncorrected clinical and parasitological cure rate (at D28 and for the first attack) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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

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Ficha completa en ClinicalTrials.gov (NCT00540410), actualizada en jun 2010.