Evaluation of efficacy and safety of Eurartesim® in patients with imported uncomplicated Plasmodium Vivax Malaria, contracted in endemic countries.

Phase 1

Conditions: Patients affected by uncomplicated Plasmodium vivax malaria
MedDRA version: 16.1Level: PTClassification code 10035503Term: Plasmodium vivax infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

Registration Number: EUCTR2013-003763-56-NL

Lead Sponsor: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 27

Inclusion Criteria

1.Have read the Information for the Patient and signed the Informed Consent Form;
2.Aged =18 years;
3.Ability to swallow oral medication;
4.Body weight comprised between 24 kg and 100 kg (included) for males and females;
5.Uncomplicated malaria with microscopically confirmed monoinfection by Plasmodium vivax or mixed infection (i.e. infection with P. vivax and other Plasmodium species);
6.Willingness to comply with the study protocol and the study visit schedule.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Participation in any investigational drug study during the previous 30 days;
2.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;
3.Known hypersensitivity to piperaquine and/or dihydroartemisinin;
4.P. vivax/Plasmodium species asexual stage parasitaemia = 5% RBCs (in cases of mixed infection);
5.Clinical and/or laboratory features of severe malaria according to WHO criteria (WHO 2010);
6.ECG abnormality that requires urgent management (i.e. clinically significant arrhythmias, AV block II and III degree etc.);
7.Family history of sudden death, or known congenital prolongation of the QT interval
8.Lengthening of QT interval on ECG: QTc (Fridericia’s correction) =450 ms for males and =470 ms for females;
9.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);
10.Any contraindication to blood sampling (i.e. important haemorrhagic diathesis);
11.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;
12.Hypoglycaemia (blood glucose levels < 2.2 mmol/L or < 40 mg/dL);
13.Splenectomy;
14.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;
15.Presence of jaundice;
16.Known renal impairment (serum creatinine > 2X the upper limit of the hospital laboratory reference range);
17.Known liver insufficiency (AST and/or ALT > 3X the upper limit of the hospital laboratory reference range);
18.Relevant anaemia (Hb< 8 g/dL).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of an Eurartesim® treatment course in patients with imported uncomplicated P. vivax malaria. The efficacy will be primarily assessed as uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 21 of follow-up.;Secondary Objective: Proportion of aparasitaemic patients (at different visits). Proportion of afebrile patients (at different visits). Day 42 uncorrected ACPR. Proportion of patients with Treatment Failure.;Primary end point(s): Uncorrected Adequate Clinical and Parasitological Response (ACPR).;Timepoint(s) of evaluation of this end point: Day 21

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of aparasitaemic patients; Proportion of afebrile patients;<br>Uncorrected ACPR;<br>Treatment Failure;Timepoint(s) of evaluation of this end point: Day 1, Day 2, Day 7 (±1), Day 21(+2) and Day 42(±2) as well as at any additional visits; <br>Day 1, Day 2, Day 7 (±1), Day 21(+2) and Day 42(±2) as well as at any additional visits;<br>Day 42(±2);<br>Any time during the study course

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