NCT00119145

A Non-Inferiority, Open-Labelled, Randomised Trial Of The Efficacy And Safety Of Artesunate-Amodiaquine, Artemether-Lumefantrine, And Artesunate-Lapdap For Treatment Of Uncomplicated P. Falciparum Malaria Among Children In Ghana

Completed Phase 4 Last updated 11 January 2017

What this trial tests

Phase 4 trial testing artesunate-amodiaquine in Malaria in 510 participants. Completed in 1 May 2006.

Timeline

1 June 2005

1 May 2006

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	510
Start date	1 June 2005
Estimated completion	1 May 2006
Sites	1 location across Ghana

Drugs / interventions tested

• artesunate-amodiaquine
• coartem (LUMEFANTRINE) — full drug profile →
• artesunate-lapdap — full drug profile →

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Adults 6 Months to 10, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• adequate clinical and Parasitological response (ACPR)by day 28.

Sponsor's own description

Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies.

Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen.

This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial.

The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An open label, randomised trial of artesunate+amodiaquine, artesunate+chlorproguanil-dapsone and artemether-lumefantrine for the treatment of uncomplicated malaria.
   Owusu-Agyei S, Asante KP, Owusu R, Adjuik M, et al · · 2008 · cited 39× · PMID 18575626 · DOI 10.1371/journal.pone.0002530