MALARIA, FALCIPARUM Clinical Trial
Official title:
In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated Plasmodium Falciparum Malaria in Malawi, 2014
This study was designed to determine the efficacy of both artemether-lumefantrine and artesunate-amodiaquine (but not to compare the efficacies of the two drugs) for the treatment of uncomplicated Plasmodium falciparum malaria at Machinga, Nkhotakota, and Karonga District Hospitals- Malawi.
Background: Malaria is a cause of substantial morbidity and mortality in Malawi. Prompt and
effective treatment of uncomplicated malaria remains a key strategy to reduce the public
health burden of malaria. Due to the rising resistance to and declining efficacy of
sulfadoxine-pyrimethamine, the first-line treatment for uncomplicated malaria from 1993 to
2007, the National Malaria Control Program (NMCP) revised the national treatment guidelines
in 2007 and again in 2013. The revised treatment guidelines recommend
artemether-lumefantrine as the first-line treatment for uncomplicated malaria and
artesunate-amodiaquine as a second-line treatment for uncomplicated malaria. Data from
Malawi suggests that these drugs remain efficacious. In a study conducted in 2004-2006 in
Blantyre, artemether-lumefantrine was found to be efficacious. A more recent assessment of
artemether-lumefantrine in vivo efficacy conducted in six sites in Malawi in 2009 also
suggests that the standard formulation artemether-lumefantrine remains highly efficacious.
In addition, both the dispersible formulation of artemether-lumefantrine (Coartem-D™) and
artesunate-amodiaquine were extremely well tolerated and safe in studies conducted in Malawi
as well as in other Sub-Saharan African countries. Given the potential for development of
parasite resistance, it is imperative to continue to monitor the efficacy of these drugs as
long as they remain the recommended treatment regimens.
Objective: Determine the efficacy of artemether-lumefantrine and co-formulated
artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria at
Machinga, Nkhotakota, and Karonga District Hospitals- Malawi
Methods: A randomized drug efficacy trial will be conducted in Malawi. The trial will
include 453 febrile children 6-59 months old with confirmed uncomplicated P. falciparum
infection, seeking care at Machinga, Nkhotakota, and Karonga District Hospitals; 151
patients will be enrolled at each site (113 for artemether-lumefantrine and 38 for
co-formulated artesunate-amodiaquine). Patients will be randomized to receive treatment with
either the dispersible formulation of artemether-lumefantrine at a dose of 2/12 mg/kg body
weight of artemether and lumefantrine, respectively, per dose, given twice a day for 3 days;
or co-formulated artesunate-amodiaquine at a dose of 4 mg/kg/day artesunate and 10 mg/kg/day
amodiaquine once a day for 3 days. Clinical and parasitological parameters will be monitored
over a 28-day follow-up period to evaluate drug efficacy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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