Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar
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ClinicalTrials.gov Identifier: NCT00465257
Recruitment Status :
(Due to lack of malaria patients in Zanzibar the study has been suspended.)
The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.
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Ages Eligible for Study:
6 Months to 59 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age below 60 months
No general danger signs or severe malaria present (see 22.214.171.124 & 126.96.36.199)
History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
No other cause of fever is detectable
No severe malnutrition
Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
Guardian/Patient has understood the procedures of the study and is willing to participate
Patient able to come for stipulated follow up visits and has easy access to the Study Site
Not able to drink or breastfeed
Recent history of convulsions
Lethargic or unconscious
Unable to sit or stand (as appropriate for age)
History of allergy to test drugs
History of intake of any drugs other than paracetamol and aspirin within 3 days