P. Falciparum Malaria Clinical Trial
Official title:
Impact Tanzania in Vivo Efficacy 2010: Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children Aged 6-59 Months
Following the rapid development of significant drug resistance to both chloroquine and
sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether-
lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that
this drug has been widely used for some time, the investigators propose to conduct an
antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if
this drug remains efficacious, or if significant resistance has emerged, in which case a new
antimalarial strategy will need to be contemplated. The investigators hypothesize that the
efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination
therapies will be equally efficacious.
Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated
with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine
(Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be
monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
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Completed |
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