Efficacy Study of Amodiaquine-Artesunate and Artemether-Lumefantrine for the Treatment of Uncomplicated Malaria
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
In the Democratic Republic of Congo (DRC), malaria is an important cause of morbidity and
mortality. It is estimated that malaria is responsible for 30% of admissions to hospital
averaged throughout the country and for 25-30% mortality in children under five.
In 2005, DRC adopted artesunate and amodiaquine (ASAQ) as first-line anti-malarial treatment.
As WHO recommended that the efficacy of antimalarial drugs was monitored regularly to avoid
an upsurge of mortality and morbidity due to continued use of ineffective drugs, a
randomized, non-inferiority open-label trial was conducted in Katanga, in order to compare
the efficacy of the fixed-dose formulation ASAQ versus artemether-lumefantrine (AL),
Children aged six and 59 months with uncomplicated Plasmodium falciparum malaria were
enrolledand randomly allocated into one of the two regimens. The risk of recurrent
parasitaemia by day 42, both unadjusted and adjusted by PCR genotyping to distinguish
recrudescence from new infection, was analysed.
Between April 2008 and March 2009, 301 childrenwere included: 156 with ASAQ and 145 with AL.
No early treatment failures were reported. Among the 256 patients followed-up at day 42, 32
patients developed late clinical or parasitological failure (9.9% (13/131) in the ASAQ group
and 15.2% (19/125) in the AL group). After PCR correction, cure rates were 98.3% (95%CI,
94.1-99.8) in the ASAQ group and 99.1% (95%CI, 94.9-99.9) in the AL group (difference -0.7%,
one sided 95%CI -3.1). Kaplan-Meier PCR-adjusted cure rates were similar. Both treatment
regimens were generally well tolerated.
Both ASAQ and AL are highly effective and currently adequate as the first-line treatment of
uncomplicated falciparum malaria in this area of Katanga, DRC. However, in a very large
country such as DRC, and because of possible emergence of resistance from other endemic
regions, surveillance of efficacy of artemisinin-based combination treatments, including
other evaluations of the resistance of ASAQ, need to be done in other provinces.
Phase:
N/A
Details
Lead Sponsor:
Epicentre
Collaborator:
Medecins Sans Frontieres, Spain
Treatments:
Amodiaquine Amodiaquine, artesunate drug combination Artemether Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Artesunate Lumefantrine