A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria

Launched by SIGMA-TAU I.F.R. S.P.A. · Nov 18, 2013

Keywords

ClinConnect Summary

Although the significant advances made during the last decades in controlling malaria in Africa, morbidity and mortality in sub-Saharan countries remain substantial. It is estimated that around 655.000 deaths a year still occur due to malaria infection and the majority of such deaths occur among young African children.

In response to the emergence and spread of classical drug-resistant Plasmodia strains, the WHO recommends since 2004 the use of artemisinin-based combination therapies (ACTs) in the treatment of uncomplicated malaria episodes.

The artemisinin derivatives are currently the m...

Gender

ALL

Eligibility criteria

• 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/microL and \<200000/microL).
• • 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.
• 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 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 National Center for Health Statistics(NCHS)/WHO reference).
• • Severe vomiting or dehydration.
• • Presence of jaundice.
• • Known hypersensitivity to the artemisinin-based therapy or piperaquine.
• • History of relevant clinical allergic reaction of any origin.
• • Clinical and/or laboratory features of severe malaria.
• • Known moderate/ severe renal or liver insufficiency.
• • Evidence of clinically relevant haematological, pulmonary, metabolic-endocrine, neurological, urogenital diseases as judged by the investigator.
• • Already diagnosed HIV infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• • Previous admission for, or evidence of symptomatic cardiac arrhythmias or with clinically relevant bradycardia at screening (bpm \< 90).
• • Family history of sudden death, or known congenital prolongation of the QT interval, or any clinical condition known to prolong the QT interval.
• • ECG abnormality that requires urgent management.
• • Any treatment which can induce a lengthening of QT interval.
• • Gastrointestinal dysfunction that could alter absorption or motility (i.e. malabsorption syndromes, intestinal sub-occlusion or previous major gastrointestinal surgery).
• • Any contraindication to blood sampling.
• • Moderate and severe anaemia (Hb \< 7 g/dL).
• • Patients who have used any drugs or substances known to be strong inhibitors of Cytochrome P enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to screening.
• • Patients who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes)within 28 days prior to screening.
• • Children lactated by HIV positive women who are undergoing treatment with antiretroviral drugs.
• • Participation in any investigational drug study during the 30 days prior to screening or previously randomised in the present trial.