Clinical Trial: Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Proof of Concept Study of Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria

Brief Summary: 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.

Detailed Summary:

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
Sponsor: sigma-tau i.f.r. S.p.A.

Current Primary Outcome: Uncorrected adequate clinical and parasitological response (ACPR) [ Time Frame: 21 days after the start of treatment ]

The uncorrected ACPR will be considered met for all those patients that are not presenting parasitaemia and fever at day 21 follow-up visit.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of aparasitaemic patients [ Time Frame: at day 1, 2, 3, 7, 21, 42 ]
    to evaluate efficacy of the treatment to clear blood from parasites
  • Proportion of afebrile patients [ Time Frame: at day 1, 2, 3, 7, 21, 42 ]
    to evaluate the efficacy of eurartesim in reducing fever caused by malaria
  • uncorrected ACPR [ Time Frame: at day 42 ]
  • Number of Patients with Serious and Non-Serious Adverse Events [ Time Frame: up to 42 days from starting of treatment ]


Original Secondary Outcome: Same as current

Information By: sigma-tau i.f.r. S.p.A.

Dates:
Date Received: April 8, 2014
Date Started: June 2014
Date Completion: February 2017
Last Updated: November 4, 2016
Last Verified: November 2016