2026-04-17T07:00:23Zhttps://recercat.cat/oai/requestoai:recercat.cat:2445/1190072025-12-05T01:54:47Zcom_2072_1057col_2072_478917
RECERCAT
author
Gargano, Nicola
author
Madrid, Lola
author
Valentini, Giovanni
author
Alessandro, Umberto d'
author
Halidou, Tinto
author
Sirima, Sodiomon
author
Tshefu, Antoinette
author
Mtoro, Ali Takadir
author
Gesase, Samwel
author
Bassat Orellana, Quique
author
Eurartesim Dispersible Study Group
2018-01-12T14:17:21Z2018-01-12T14:17:21Z2017-10-232017-11-01T18:59:57Z
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.
cc by (c) Gargano et al., 2017 http://creativecommons.org/licenses/by/3.0/es/ info:eu-repo/semantics/openAccess
Malària
Infants
Malaria
Children
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
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion