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

NCT00378625 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2006-09-20

No results posted yet for this study

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

DRUG

Artesunate

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • Centro Internacional de Entrenamiento e Investigaciones Médicas

    lead OTHER

Principal Investigators

  • Lyda Osorio, MD PhD · Centro Internacional de Entrenamiento e Investigaciones Médicas

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-30
Completion
2006-03-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00378625 on ClinicalTrials.gov