Malaria, Vivax Clinical Trial
Official title:
Proof of Concept Study of Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria
The aim of the present study is to investigate the efficacy, safety and tolerability of a therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P. vivax in endemic countries.
Vivax malaria occurs throughout the tropical, subtropical and some of the temperate latitudes
globally. During a primary infection some P. vivax parasites become dormant in the liver
(hypnozoites) during large periods of time and might subsequently cause multiple blood-stage
relapses.
The asexual stages of P. vivax are generally still sensitive to chloroquine (CQ) throughout
most of the world with the exception of Indonesia and Papua New Guinea where high therapeutic
failure rates ranging from 5-84% have been reported. Also, there are reports of chloroquine
failure from other countries and regions where the species is endemic; in particular, the
presence of CQ-resistant vivax strains is now well described in several countries, including
India, Brazil, Peru and Colombia.
The treatment of the dormant stages and the prevention of relapses is reached throughout the
8-aminoquinolines (primaquine is the only commercially available in this indication).
The current treatments recommended by World Health Organization (WHO) for the radical cure of
CQ-resistant vivax malaria are Artemisinin based Combination Therapies (ACTs) with partner
drugs having very long half-life, combined with a two weeks regiment of primaquine (WHO,
2010).
Among a variety of suitable artemisinin-based combinations, the fixed combination of
dihydroartemisinin (DHA) and piperaquine (PQP )is considered an excellent therapeutic
approach since it has got all the requirements considered essential for showing a positive
benefit/risk ratio in malaria therapy.
Sigma-Tau i.f.r. S.p.A. has developed a DHA+PQP formulation (Eurartesim®) manufactured
according to international Good Manufacturing Practice (GMP) standards and has recently
received marketing authorization in Europe via a centralized procedure by the European
Medicine Agency (EMA) for uncomplicated episodes of P. falciparum malaria.
A substantial amount of data have been collected in patients with uncomplicated P. falciparum
malaria treated with the DHA+PQP combination. In addition, several studies have provided
evidence of high cure rate in patients with P. vivax malaria treated with DHA+PQP, however,
no data are available so far on efficacy and safety of the DHA+PQP treatment in patients with
imported P. vivax malaria. Acquiring data is therefore of particular importance since malaria
represents an important burden among all travel-acquired illnesses considering not only the
number of cases (10-20% of the imported malaria cases are due to P. vivax infection) but also
the potential of a fatal outcome.
The aim of the present study is to investigate the efficacy, safety and tolerability of a
therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P.
vivax in endemic countries. The results of such "proof of concept" study will be used for
estimating the failure rate in a precise way and to dimension one or more subsequent phase
III trials of comparative efficacy.
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