Randomized Trial on Effectiveness of ACTs in Ghana

November 26, 2007 updated by: Bernhard Nocht Institute for Tropical Medicine

A Comparative Assessment of the Effectiveness of Artemether Plus Lumefantrine Versus Artesunate Plus Amodiaquine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria

The purpose of this study is to compare the effectiveness and safety of two Artemisinin Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium falciparum malaria

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Childhood mortality related to Plasmodium falciparum malaria is on the rise with more than 1 million deaths per year in Sub-Saharan Africa. In the context of growing drug-resistance to antimalarials health officials are calling for rapid replacement of failing drugs by combining antimalarial drugs. Artemisinin Combination Antimalarial Therapies (ACTs) are in the focus of malaria control programmes and are recommended for first-line treatment in African countries. ACTs have been reported to be highly effective as artemisinin derivatives cause a rapid and substantial decrease in the parasite load when used for treating patients with malaria and resistance to artemisinin is still lacking. However, the short half-lives of artemisinins result in frequent recrudescent infections when used alone and therefore, much interest lays on the choice of the combination partner drug. ACTs also have been proposed as a means of reducing transmission by the reduction of gametocytes and of delaying the spread of drug resistance and prolonging the therapeutic life span of. Nevertheless, drug resistance of parasites to the respective partner drug is a matter of concern. Artesunate-amodiaquine (AQ) and artemether-lumefantrine (AL) are two registered fixed-dose artemisinin combination chemotherapies used in Africa which are GMP-manufactured at industrial scale. There is still limited data from randomised, controlled trials to support the general effectiveness of these two ACTs in Africa, including Ghana. More data is needed to compare these two therapies to make evidence-based first-line treatment decisions. Importantly, it is difficult to predict how combination therapy may affect the spread of drug resistance and monitoring drug resistance markers should be embedded in these trials to guide drug policy decision.

The aim of this open-labelled, randomised drug trial is to compare the effectiveness and safety of artesunate-amodiaquine (Arsucam®) against artemether plus lumefantrine (Coartem®) for the treatment of children under five years of age with uncomplicated Plasmodium falciparum malaria.

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 4

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
    • Asante Akim North District
      • Agogo, Asante Akim North District, Ghana
        • Agogo Presbyterian 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 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female outpatients aged 6 months to 59 months
  • Absence of severe malnutrition
  • A slide-confirmed P. falciparum asexual parasitaemia between 2,000/µl and 200,000/µl
  • A measured axillary temperature ≥ 37.5 °C or rectal/tympanic temperature ≥ 38.0 °C
  • Absence of general danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit)
  • Ability to tolerate oral therapy
  • Permanent residence in study area
  • Informed consent by the legal representative of the subject, if possible, the parents

Exclusion Criteria:

  • Adequate anti-malarial treatment within the previous 7 days
  • Antibiotic treatment for a current infection
  • Previous participation in a clinical trial
  • Haemoglobin < 5 g/dl
  • Leucocyte count: > 15000/µl
  • Mixed plasmodial infection
  • Severe malaria as defined by WHO recommendations
  • Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) or concomitant disease masking assessment of response
  • History of allergy or intolerance against trial medication

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL
Artemether plus Lumefantrine 6 dose 3 days treatment
Drug: Artemether-Lumefantrine
Artemether 20 mg/Lumefantrine 120mg fixe-dose-combination tablets: 3 days twice daily weight-adjusted dosing according to manufacturer
Other Names:
  • Coartem®
Active Comparator: ASAQ
Artesunate plus Amodiaquine
Drug: Artesunate plus Amodiaquine
Artesunate 50 mg and Amodiaquine 153 mg co-blister tablets: 3 days once daily weight-adjusted dosing according to manufacturer
Other Names:
  • Arsucam®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical and PCR-controlled parasitological cure rate at day 28
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical and PCR-controlled parasitological cure rate at day 14
Time Frame: 14 days
14 days
Effect on anaemia
Time Frame: 28 days
28 days
Molecular Drug Resistance Markers
Time Frame: 28 days
28 days
Recrudescence and Reinfection
Time Frame: 28 days
28 days
Effects on Gametocytemia
Time Frame: 28 days
28 days
Acceptance of Therapies
Time Frame: 7 days
7 days
Incidences of malaria episodes over a follow-up period of 1 year
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Bernhard Nocht Institute for Tropical Medicine

Collaborators

Kumasi Centre for Collaborative Research (KCCR)
Presbyterian Health Service (PHS)
School of Medical Sciences Kumasi (SMS/KNUST)

Investigators

  • Principal Investigator: Daniel Ansong, MD, School of Medical Science (SMS), Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, Ghana

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

Helpful Links

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

September 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 8, 2006

First Submitted That Met QC Criteria

September 8, 2006

First Posted (Estimate)

September 11, 2006

Study Record Updates

Last Update Posted (Estimate)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01KA22062006

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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