Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02110784
• Date of registration: 08/04/2014
• Prospective Registration: Yes
• Primary sponsor: Alfasigma S.p.A.
• Public title: Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria
• Scientific title: Proof of Concept Study of Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria
• Date of first enrolment: June 18, 2014
• Target sample size: 27
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02110784
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France, Germany, Israel, Italy, Netherlands, Spain, Switzerland

Contacts

• Name: Christoph Hatz, Prof Dr Med
• Affiliation: Medical and Diagnostic Service Department, Swiss Tropical and Public Health Institute, Basel - Switzerland

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria, Vivax

Intervention(s)

Drug: Eurartesim tablets

Primary Outcome(s)

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

Secondary Outcome(s)

Number of Patients with Serious and Non-Serious Adverse Events [Time Frame: up to 42 days from starting of treatment]

uncorrected ACPR [Time Frame: at day 42]

Proportion of aparasitaemic patients [Time Frame: at day 1, 2, 3, 7, 21, 42]

Proportion of afebrile patients [Time Frame: at day 1, 2, 3, 7, 21, 42]

Secondary ID(s)

2013-003763-56

ST3073-ST3074-DM13-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors