Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria

• Status: Terminated
• Trial end date: 2017-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alfasigma S.p.A.; sigma-tau i.f.r. S.p.A.
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion Criteria:

• Have read the Information for the Patient and signed the Informed Consent Form;

• Aged ≥18 years and able to swallow oral medication;

• Body weight comprised between 24 kg and 100 kg (included) for males and females;

• Uncomplicated malaria with microscopically confirmed monoinfection by Plasmodium vivax or mixed infection (i.e. infection with P. vivax and other Plasmodium species);

• Willingness to comply with the study protocol and the study visit schedule.

Exclusion Criteria:

• Participation in any investigational drug study during the previous 30 days;

• Antimalarial treatment with chloroquine and quinine within the previous 6 weeks, with piperaquine-based compounds or mefloquine or lumefantrine within the previous 3 months and with halofantrine within the previous 30 days prior to screening;

• P. vivax/Plasmodium species asexual stage parasitaemia ≥ 5% Red Blood Cells (in cases of mixed infection);

• Clinical and/or laboratory features of severe malaria according to WHO criteria (WHO 2010);

• ECG abnormality that requires urgent management (i.e. clinically significant arrhythmias, Atrio-Ventricular block II and III degree etc.);

• Family history of sudden death, or known congenital prolongation of the QT interval

• Lengthening of QT interval on ECG: corrected QT interval (Fridericia's correction) ≥450 ms for males and ≥470 ms for females;

• Concomitant administration of any treatment which can induce a lengthening of QT interval (i.e. antihistamines, macrolides, etc.) and of any antimalarial drugs (for the full list of prohibited drugs refer to section 8.3);

• Any contraindication to blood sampling (i.e. important haemorrhagic diathesis);;

• Presence of intercurrent illness or any condition (i.e. severe vomiting and dehydration) which in the judgement of the Investigator would place the patient at undue risk or interfere with the study results;

• Hypoglycaemia (blood glucose levels < 2.2 mmol/L or < 40 mg/dL);

• Splenectomy;

• Pregnant or lactating women. During the study period (Day 0- Day 42), fertile women who are sexually active must use an adequate birth control method. They should utilize oral or patch contraceptives, contraceptive implant or depot injection or an intrauterine device from at least one month before screening and during the whole study period. In all the other cases they have to agree to remain inactive or use condoms with a spermicidal agent during the study period;

• Presence of jaundice;

• Known renal impairment (serum creatinine > 2X the upper limit of the hospital laboratory reference range);

• Known liver insufficiency (AST and/or ALT > 3X the upper limit of the hospital laboratory reference range);

• Relevant anaemia (Hb< 8 g/dL).