A phase II, open-label, multicentre, pharmacokinetic, pharmacodynamics and safety study of a new paediatric eurartesim dispersible formulation and crushed film coated eurartesim tablet, in infant patients with Plasmodium falciparum malaria

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.0 个研究点目标入组 300 人开始时间: 2014年11月4日最近更新: 2014年11月10日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.