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Randomized , comparative study of the efficacy and safety of artesunate plus amodiaquine , administered as a single daily intake versus two daily intakes in the treatment of uncomplicated falciparum malaria . BACKGROUND Artesunate plus amodiaquine is a coblistered ACT , given as a single daily intake . It has been suggested that , in view of the number of tablets to be taken ( particularly in adults ) , it may be possible to improve compliance by allowing patients to divide the daily dose . The objectives of this randomized , comparative , open-label , multicentre study , conducted in Senegal and in Cameroon in 2005 , was to demonstrate the non-inferiority and to compare the safety of artesunate plus amodiaquine , as a single daily intake versus two daily intakes . METHODS A three-day treatment period and 14-day follow-up period was performed in any subject weighting more than 10 kg , presenting with a malaria paroxysm confirmed by parasitaemia > or = 1,000/microl , after informed consent . Patients were randomly allocated into one of the two regimens , with dosage according to bodyweight range . All products were administered by an authorized person , blinded to both the investigating physician and the biologist . The primary endpoint was an adequate response to treatment on D14 ( WHO definition ) . The two-sided 90 % confidence interval of the difference was calculated on intent to treat ( ITT ) population ; the acceptance limit for non-inferiority was 3 % . The safety was evaluated by incidence of adverse events . RESULTS Three-hundred and sixteen patients were included in the study . The two patient groups were strictly comparable on D0 . The adequate responses to treatment were similar for the two treatment regimens on D14 , PCR-corrected ( 99,4 % in the one-daily intake group versus 99,3 % in the comparative group ) . The statistical analyses demonstrated the non-inferiority of administering artesunate/amodiaquine as two intakes . The drug was well tolerated . The main adverse events were gastrointestinal disorders ( 2.5 % ) and pruritus ( 2.5 % ) ; safety profiles were similar in the two groups . CONCLUSION This pilot study confirms the efficacy and good tolerability of artesunate plus amodiaquine , administrated either in one or in two daily intakes .
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Intervention_Pharmacological
artesunate plus amodiaquine
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Intervention_Pharmacological
amodiaquine
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Mental
compliance
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Outcome_Mental
non-inferiority
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Outcome_Other
safety of artesunate plus amodiaquine
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Outcome_Physical
adequate response to treatment on D14
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Outcome_Adverse-effects
incidence of adverse events
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Outcome_Other
adequate responses to treatment
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Outcome_Mental
non-inferiority
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Outcome_Other
well tolerated
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Outcome_Adverse-effects
gastrointestinal disorders
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Participant_Condition
uncomplicated falciparum malaria .
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Participant_Sample-size
Three-hundred and sixteen