Malaria,Falciparum Clinical Trial
Official title:
A Phase II, Open-label, Multicentre, Pharmacokinetic, Pharmacodynamics and Safety Study of a New Paediatric Eurartesim Dispersible Formulation and Crushed Film Coated Eurartesim Tablet, in Infant Patients With P. Falciparum Malaria
There is a need for paediatric formulations that permit accurate dosing and enhance patient
compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations
are available on the market. Thus, a new water dispersible formulation of eurartesim has
been developed for oral administration.
Aim of this study is to provide data on pharmacokinetic profile, safety and efficacy of this
new paediatric formulation and compare it with the crushed film coated tablet in infant
patients (6 to ≤12 months of age) suffering from uncomplicated Plasmodium falciparum
malaria.
Furthermore, a Pharmacokinetic/Pharmacodynamic(PK/PD) modelling will be built up to
establish PK/PD relationship in adult and paediatric populations.
Although the significant advances made during the last decades in controlling malaria in
Africa, morbidity and mortality in sub-Saharan countries remain substantial. It is estimated
that around 655.000 deaths a year still occur due to malaria infection and the majority of
such deaths occur among young African children.
In response to the emergence and spread of classical drug-resistant Plasmodia strains, the
WHO recommends since 2004 the use of artemisinin-based combination therapies (ACTs) in the
treatment of uncomplicated malaria episodes.
The artemisinin derivatives are currently the most rapidly acting and potent antimalarial
drugs.
Eurartesim is a fixed-dose combination product composed of dihydroartemisinin (DHA) and
piperaquine phosphate (PQP). This second compound assures the long-term efficacy of
eurartesim completing the whole body cleaning from the parasites. Eurartesim appears to
offer benefits over existing licensed malaria treatments and is in line with current WHO
treatment policy recommendations.
Eurartesim obtained a centralized marketing authorization by the European Union as film
coated tablets containing 160 mg PQP/20 mg DHA and 320 mg PQP/40 mg DHA. The drug, licensed
for its use in children (above 6 months of age) and adults has been administered in infants
(above 6 months) and young children by crushing the tablets and administering them with a
small amount of water.
According to the Guidelines on Clinical Investigation of Medicinal Products in the
Paediatric Population (EMA ICH Topic E 11), there is a need for paediatric formulations that
permit accurate dosing and enhance patient compliance.
However, for the treatment of malaria, scarce paediatric-friendly formulations are available
on the market, and this is a particularly blatant problem as young children carry the brunt
of the malaria burden. Thus, a new water dispersible formulation of eurartesim has been
developed for oral administration, since liquid formulations may be needed or desirable for
paediatric patients of smaller ages due to their inability to swallow tablets. Moreover, in
order to increase paediatric compliance to treatment, the new formulation is prepared with
acceptable flavour and sweetener for children.
Eurartesim is a promising effective ACT treatment for malaria. It provides a simple dosing
scheme (a single daily dose over 3 days) and it does not need any concomitant administration
of food to improve its absorption. Moreover, eurartesim offers an interesting post-treatment
prophylactic effect following therapy, reducing the risk of new infection, an issue of
particular relevance in highly endemic malaria countries.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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