A phase II study to compare a new paediatric eurartesim dispersible formulation and crushed film coated eurartesim tablet, in infant patients with Plasmodium falciparum malaria

• Conditions: ncomplicated Plasmodium falciparum malaria; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2013-002255-15-Outside-EU/EEA
• Lead Sponsor: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-04
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•Male and Female infants aged from 6 months to = 12 months included.
•Ability to swallow oral suspension.
•Body weight ?5 kg.
•Uncomplicated malaria, with microscopically confirmed mono-infection by P. falciparum (parasitaemia =1000/?L and <200000/?L).
•History of fever anytime during the preceding 48 hours or presence of fever (axillary temperature =37.5 °C or =38.0 °C rectally).
•Ability of parents or guardians to understand the nature of the trial and providing signed informed consent.
•Stable residence in the study area during the two months after recruitment and willingness to comply with the study protocol and the study visit schedule.

Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Antimalarial treatment with amodiaquine, chloroquine, quinine or lumefantrine-based compounds within the previous 6 weeks, with piperaquine-based compound, or mefloquine, or sulphadoxine pyrimethamine (SP) within the previous 3 months and with halofantrine within the 30 days prior to screening.
•Any other antimalarial treatment or antibiotics with antimalarial activity (including cotrimoxazol) and any herbal products, within the 7 days prior to screening.
•Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).
•Severe vomiting or dehydration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified