NCT00378625

Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia

Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (planned)
• Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas · Academic / Other
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of: * Efficacy * Tolerability * Time of fever clearance * Time of parasite clearance * Proportion of gametocyte carriers

Conditions

• Malaria,Falciparum
• Malaria
• Antimalarials

Interventions

Type	Name	Description
DRUG	Artesunate

Timeline

• Start date: 2000-04-01
• Completion: 2006-03-01
• First posted: 2006-09-20
• Last updated: 2006-09-20

Locations

1 site across 1 country: Colombia