Malaria Clinical Trial
Official title:
Confirmation of Artemisinin Tolerance in Malaria Parasites Trial in Kilifi
The purpose of this study is to determine whether P. falciparum infections in Kilifi District have developed tolerance to the artemisinin class of drugs.
Artemisinin-based combination therapies (ACT) are the treatment of choice for episodes of
uncomplicated P. falciparum malaria in all endemic countries. Rapid clearance of pathogenic
blood stage malaria parasites by artemisinins is associated with swift recovery from mild
malaria and reduced mortality from severe forms of the disease. In Kenya, and most malaria
endemic sub-saharan Africa, artemether-lumefantrine has been introduced as first-line
treatment in the public health care sector in 2006. Alarmingly, despite the short time since
the introduction of ACTs artemisinin-resistant P. falciparum malaria has already emerged in
South-East Asia, an area that has historically been the cradle of global spreads of
drug-resistant malaria parasites.
In a previous study in Kilifi we have observed a significant drop in early response rates to
treatment with two ACTs from 2005 to 2008. Conventional markers of potential changes in
anti-parasitic host immunity, drug exposure, or baseline parasite biomass could not account
for the observed time-dependent change in response rates.
This protocol aims to establish with reasonable confidence whether P. falciparum infections
in Kilifi District have developed tolerance to the artemisinin class of drugs. We propose to
study treatment response rates to an established 7-day regimen of artesunate alone in the
treatment of uncomplicated P. falciparum malaria in children aged 6 months to 10 years, at
the KEMRI study site in Pingilikani, Kilifi District, Kenya. The study will also assess (i)
pharmacokinetic parameters of artesunate; (ii) ex vivo and in vitro chemosensitivity of
parasite isolates to DHA; (iii) genetic determinants of altered in vivo and in vitro
responses to DHA; and (iv) ex vivo expression profiles in normally vs. slowly responding P.
falciparum infections before and during treatment.
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