# name
A new water-dispersible paediatric formulation of
                dihydroartemisinin-piperaquine for the treatment of
                uncomplicated Plasmodium falciparum malaria in African infants:
                efficacy and tolerability outcomes of a phase II, randomized,
                open label, multicenter study

# metadata.dc.description.abstract[].value
Artemisinin combination therapies are considered the mainstay of
                malaria treatment, but paediatric friendly formulations for the
                treatments of infants are scarce. We aimed 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(R)) in the treatment of
                infants with uncomplicated P. falciparum malaria.Reported here
                are the results of a large phase II, randomized, open label,
                multicenter trial conducted in African infants (6-12 months of
                age) from Mozambique, Burkina Faso, The Gambia, DR-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.Two-hundred and one patients
                received the dispersible tablet formulation and 99 the
                conventional one administered as crushed tablets. At day 28, the
                PCR-corrected ACPR was 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, it was 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
                three-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.

# metadata.dc.relation.isformatof[].value
Reproducció del document publicat a:
                http://dx.doi.org/10.1128/AAC.00596-17

# metadata.dc.relation.ispartof[].value
Antimicrobial Agents and Chemotherapy, 2017, vol. 62, num. 1, p. e00596-17

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
A new water-dispersible paediatric formulation of
                dihydroartemisinin-piperaquine for the treatment of
                uncomplicated Plasmodium falciparum malaria in African infants:
                efficacy and tolerability outcomes of a phase II, randomized,
                open label, multicenter study