Kintampo Trial of Combination Therapy for Malaria
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- adequate clinical and Parasitological response (ACPR)by day 28.
- Parasitological cure rate by day 14
- Parasitological cure rate by day 28
- Clinical cure rates by days 14 and 28
- Incidence rates of adverse events
- Gametocyte carriage at days 7, 14 and 28
|Study Start Date:||June 2005|
|Study Completion Date:||May 2006|
|Kintampo Health Research Centre|
|Kintampo, Brong Ahafo Region, Ghana|
|Principal Investigator:||Seth Owusu-Agyei, PhD||London School of Hygiene and Tropical Medicine|
|Principal Investigator:||Daniel Chandramohan, MBBS, PhD||London School of Hygiene and Tropical Medicine|
|Principal Investigator:||Brian M Greenwood, FRCP, FRS||London School of Hygiene and Tropical Medicine|