Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children

November 30, 2006 updated by: University of Ghana Medical School
Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Ghana
      • Accra, Ghana
        • Korle Bu Teaching Hospital

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

6 months to 14 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • microscopically confirmed acute uncomplicated falciparum malaria;
  • temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
  • willingness to comply with follow up schedule;
  • written informed consent by accompanying parent or guardian

Exclusion Criteria:

  • features of severe malaria or danger signs of malaria
  • known intolerance or allergy to any of the study medications
  • known treatment with any of the study medications in the month preceding enrollment
  • serious underlying disease that may mask outcome assessment

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

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

Sponsor

University of Ghana Medical School

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: George O. Adjei, MD, Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
  • Principal Investigator: Bamenla Q. Goka, MBchB, Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
  • Principal Investigator: Jorgen A.L. Kurtzhals, MD, Ph.D, Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

November 13, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 30, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91199 / 104. DAN.8-864
  • GHN-202-M03-M-00

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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