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ARTESUNATE + AMODIAQUINE

Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

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

Fase

Fase 3

Estado

Completado

Participantes

380

previstos

Centros

1

Fin del objetivo primario

jun 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ene 2012.

Qué mide

Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction (del registro, en inglés) (28 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: \- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine Secondary Objectives: * To assess the non inferiority on the same way as the main criteria: * at Day 28 before corrected cure rate * at Day 14 and Day 42 before and after corrected cure rate * To compare the two groups of treatment in terms of: * Efficacy: * Proportion of aparasitaemic patients at 24, 48 an 72 hours * Proportion of afebrile patients at 24, 48 and 72 hours * Percentage of gametocyte carriers during follow-up * Evolution of the mean of gametocytes during the 42 days of follow-up * Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28 * Clinical and biological tolerability: * Proportion of any adverse event * Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins) * ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above

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Ficha completa en ClinicalTrials.gov (NCT01378286), actualizada en jul 2013.