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

September 19, 2006 updated by: Centro Internacional de Entrenamiento e Investigaciones Médicas

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Choco
      • Quibdo, Choco, Colombia, 00
        • Hospital Ismael Roldan and Centro de Salud San Vicente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. pure P. falciparum infection
  2. parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL)
  3. age between 1 and 65 years old
  4. availability to return for follow-up

Exclusion Criteria:

  1. Pregnancy
  2. history of allergy to the study drugs
  3. history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
  4. have a medical history of untreated hypertension or chronic heart, kidney or liver disease
  5. present any danger signs of severe malaria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
adverse events
treatment failures
gametocyte carriage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Collaborators

World Health Organization
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Investigators

  • Principal Investigator: Lyda Osorio, MD PhD, Centro Internacional de Entrenamiento e Investigaciones Médicas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 20, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2006

Last Update Submitted That Met QC Criteria

September 19, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00096/990954
  • 2229-04-10380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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