Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02110784
Study type Interventional
Source Alfasigma S.p.A.
Contact
Status Terminated
Phase Phase 2
Start date June 18, 2014
Completion date April 30, 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05096702 - Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
Recruiting NCT05540470 - Radical CUREfor MAlaria Among Highly Mobile and Hard-to-reach Populations in the Guyanese Shield N/A
Active, not recruiting NCT04079621 - Short Course Radical Cure of P. Vivax Malaria in Nepal Phase 4
Completed NCT03307369 - A Retrospective Study of Severe Plasmodium Vivax
Completed NCT01213966 - Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection Phase 2
Completed NCT00811096 - Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax Phase 2
Terminated NCT03337152 - Assessing a Risk Model for G6PD Deficiency Phase 4
Completed NCT05753150 - Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand
Completed NCT02751294 - A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution Phase 1
Recruiting NCT05058885 - Plasmodium Vivax Among Duffy Negative Population in Cameroon.
Completed NCT03377296 - Study of Controlled Human Plasmodium Vivax Infection N/A
Completed NCT00486694 - Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria Phase 2
Recruiting NCT05788094 - ACT vs CQ With Tafenoquine for P. Vivax Mono-infection Phase 4
Not yet recruiting NCT05690841 - FocaL Mass Drug Administration for Vivax Malaria Elimination Phase 3
Not yet recruiting NCT04739917 - Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune Volunteers Phase 2
Completed NCT03208907 - DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil Phase 3
Completed NCT02184637 - A Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine Co-administered With Either Artemether + Lumefantrine or Dihydroartemisinin + Piperaquine Tetraphosphate Phase 1
Completed NCT01928914 - Tafenoquine Thorough QTc Study in Healthy Subjects Phase 1
Completed NCT01081847 - Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants Phase 1
Completed NCT00157885 - A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia. N/A