Status:
COMPLETED
Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia
Lead Sponsor:
Centro Internacional de Entrenamiento e Investigaciones Médicas
Collaborating Sponsors:
World Health Organization
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Conditions:
Malaria,Falciparum
Malaria
Eligibility:
All Genders
1-65 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- pure P. falciparum infection
- parasitaemia \>500 and \<50,000 asexual parasites/μL (subsequently the lower limit was modified to \>250 asexual parasites/μL)
- age between 1 and 65 years old
- availability to return for follow-up
Exclusion
- Pregnancy
- history of allergy to the study drugs
- history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
- have a medical history of untreated hypertension or chronic heart, kidney or liver disease
- present any danger signs of severe malaria.
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00378625
Start Date
April 1 2000
End Date
March 1 2006
Last Update
September 20 2006
Active Locations (1)
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1
Hospital Ismael Roldan and Centro de Salud San Vicente
Quibdó, Departamento del Chocó, Colombia, 00