Abstract
ABSTRACTArtemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new dispersible-tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. Reported here are the results of a large phase II, randomized, open-label, multicenter trial conducted in African infants (6 to 12 months of age) from Mozambique, Burkina Faso, The Gambia, the Democratic Republic of the Congo, and Tanzania. Primary efficacy endpoint was the PCR-corrected adequate clinical and parasitological response (ACPR) at day 28. Analysis was performed for the intention-to-treat (ITT) and per-protocol (PP) populations. A total of 201 patients received the dispersible-tablet formulation, and 99 received the conventional one administered as crushed tablets. At day 28, the PCR-corrected ACPRs were 86.9% (ITT) and 98.3% (PP) in the dispersible-tablet group and 84.9% (ITT) and 100% (PP) in the crushed-tablet group. At day 42, these values were 85.9% (ITT) and 96.5% (PP) in the dispersible-tablet group and 82.8% (ITT) and 96.4% (PP) in the crushed-tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences (P = 0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of adverse events and was consistent with that expected in African infants with malaria. A standard 3-day treatment with the new dispersible DHA/PQP formulation is as efficacious as the currently used tablet in African infants and has a comparable safety profile. (This trial was registered at ClinicalTrials.gov under registration no. NCT01992900.)
Highlights
Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce
We present here the results of a multicenter trial in sub-Saharan Africa aiming to assess the efficacy, tolerability and safety of the new dispersible-tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/piperaquine phosphate (PQP)) with respect to the marketed formulation, administered as a crushed tablet, to infant patients with uncomplicated P. falciparum malaria
According to guidelines on the clinical investigation of medicinal products in a pediatric population, there is a need to develop new formulations that allow accurate dosing and enhance patient compliance in infants and young children [16]. This recommendation becomes even more necessary for the treatment of malaria, as young children and infants are those most affected by the disease, and very few GMPproduced pediatric-friendly formulations are available [15]
Summary
Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new dispersible-tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. The efficacy and safety of Eurartesim for the treatment of uncomplicated Plasmodium falciparum malaria has been demonstrated in two phase III trials, respectively conducted in 1,553 African children and 1150 Asian adults and children [10, 11]. Both studies demonstrated an equivalent efficacy of DHA/PQP versus the comparative ACT. Eurartesim obtained by the WHO the prequalification status on 9 October 2015 [13]
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