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Coarsucam · SMART-CURE

Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) 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

413

previstos

Centros

1

Fin del objetivo primario

jun 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2008.

Qué mide

PCR corrected and uncorrected clinical and parasitological cure rate (del registro, en inglés) (en el dia 28)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Secondary objectives: For the first attack: To compare the 2 groups of treatment in terms of: * Day 42 efficacy * Parasitological and fever clearance * Clinical and Biological tolerability * Evolution of gametocyte carriage For attack 2nd and following: To compare the 2 groups of treatment in terms of: * Day 28 and Day 42 clinical and parasitological effectiveness * Clinical and Biological tolerability * Proportion of patients without fever at Day 3 * Proportion of patients without parasites at Day 3 * Evolution of gametocyte carriage * Compliance During the total follow up of the cohort: To compare the 2 groups of treatment in terms of: * Treatment incidence density * Impact of repeated treatment on clinical and biological tolerability * Impact on anaemia * Impact on Hackett score.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00699920), actualizada en jun 2010.