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RTS,S/AS01(E) integrated in the EPI showed a favorable safety and immunogenicity evaluation. Trial registration. ClinicalTrials.gov identifier: NCT00436007 . GlaxoSmithKline study ID number: 106369 (Malaria-050).

Enlisting traditional healers and pharmacists to improve TB detection contributed 38% to 70% of new smear-positive case notifications per quarter in a rural district of Tanzania.

The pharmacokinetic and pharmacodynamic properties of a new pediatric formulation of artemetherlumefantrine, dispersible tablet, were determined within the context of a multicenter, randomized, parallelgroup study. In an exploratory approach, we compared a new pediatric formulation with the tablet formulation administered crushed in the treatment of African children with uncomplicated Plasmodium falciparum malaria. Patients were randomized to 3 different dosing groups (weights of 5 to <15 kg, 15 and <25 kg, and 25 to <35 kg). Treatment was administered twice daily over 3 days. Plasma concentrations of artemether and its active metabolite, dihydroartemisinin (DHA), were determined at 1 and 2 h after the first dose of dispersible (n ‫؍‬ 91) and crushed (n ‫؍‬ 93) tablets. A full pharmacokinetic profile of lumefantrine was reconstituted on the basis of 310 (dispersible tablet) and 315 (crushed tablet) plasma samples, collected at 6 different time points (1 sample per patient). Dispersible and crushed tablets showed similar artemether and DHA maximum concentrations in plasma (C max ) for the different body weight groups, with overall means of 175 ؎ 168 and 190 ؎ 168 ng/ml, respectively, for artemether and 64.7 ؎ 58.1 and 63.7 ؎ 65.0 ng/ml, respectively, for DHA. For lumefantrine, the population C max were 6.3 g/ml (dispersible tablet) and 7.7 g/ml (crushed tablet), whereas the areas under the concentration-time curves from time zero to the time of the last quantifiable plasma concentration measured were 574 and 636 g ⅐ h/ml, respectively. For both formulations, descriptive quintile analyses showed no apparent association between artemether/DHA C max and parasite clearance time or between the lumefantrine C max and the occurrence of adverse events or corrected QT interval changes. The results suggest that the dispersible tablet provides adequate systemic exposure to artemether, DHA, and lumefantrine in African children with uncomplicated P. falciparum malaria.Artemisinin-based combination therapies (ACTs) are currently the best available treatments for uncomplicated Plasmodium falciparum malaria because of their fast action, reliable efficacy, good safety profile, and potential to lower the emergence and spread of drug resistance (2,6,18,20). Artemetherlumefantrine (A-L; Coartem) was the first fixed-dose ACT prequalified by the World Health Organization (WHO) and has subsequently been adopted by many countries in sub-Saharan Africa as first-line treatment for uncomplicated P. falciparum malaria (26). The recommended 6-dose regimen of A-L, twice a day for 3 days, has been proven to be efficacious and safe in both infants and children weighing 5 to 35 kg and adults weighing Ͼ35 kg (11,13,15,17).In young children, A-L is usually administered as a crushed tablet (CT). In an effort to ease administration of A-L, a sweetened cherry-flavored A-L dispersible tablet (DT) formulation containing the same amounts of artemether and lumefantrine as the standard tablet was developed. Pharmacokinetic assessments were performed withi...