Malaria Paediatrics
Conditions
Interventions
artemether lumefantrine
No Control group in this study
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female neonates / infants 2. Body weight 28 days; in Cohort 2, neonates aged 1 to =28 days (3 subgroups: 15-28 days; 8-14 days; 1-7 days) 4. Microscopically confirmed diagnosis of P. falciparum malaria (or mixed infections) • in Cohort 1: of =500 and <100,000 parasites/µL asexual P. falciparum parasitemia • in Cohort 2: of =100 and <100,000 parasites/µL asexual P. falciparum parasitemia • either congenital or neonatal • either symptomatic or asymptomatic
Exclusion criteria
Exclusion criteria: 1. Head circumference < - 2 SD z-score in cm following WHO age and sex-specific reference curves (suspicion of microcephaly) 2. Severe malnutrition 3. Presence of severe malaria (according to WHO 2015 definition) 4. HIV status: • in Cohort 1 : patient’s or patient's mother's current treatment with ARV • in Cohort 2 : Mother’s known HIV positive status at patient's birth or mother's current treatment with ARV 5. Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants, WHO 2005) 6. Presence of any clinically significant neurological condition: • any episode of convulsion during the present illness (in keeping with the IMCI list of general danger signs) • known neurological disorders (e.g. chronic seizure disorders, cerebral palsy) 7. Presence of clinically significant abnormality of the hepatic and renal systems 8. History of malabsorption or previous gastrointestinal surgery, or history of radiation therapy that could affect drug absorption or metabolism, or any other disorder or history of a condition that could interfere with drug absorption, distribution, metabolism, or excretion 9. Known hypersensitivity of the patient or either patient's parent to artemether, lumefantrine, any of the excipients of Coartem®/Riamet® Dispersible tablet, or to drugs of similar chemical classes 10. Known family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease 11. Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia) 12. Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Artemether Cmax (represents the higher concentration between the concentrations at 1 hour and 2 hours after first dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lumefantrine Day 8 concentration (C168h) Artemether AUC, DHA and Lumefantrine Cmax and AUC as appropriate;Serious adverse events (SAEs), adverse events (AEs), and routine safety laboratory assessments;PCR-corrected Adequate Clinical and parasitological Response (ACPR) at Days 15, 29, and 43 Uncorrected ACPR at Days 8, 15, 29, and 43 Incidence rate of recrudescence and new infections at Days 15, 29 and 43 Parasite and Fever clearance Times (PCT and FCT) | — |
Countries
Burkina Faso, Democratic Republic of the Congo
Contacts
Public ContactNovartis Pharma AG Novartis Pharma AG
Trial Director
Outcome results
None listed