Malaria Paediatrics
Conditions
Interventions
Dihydroartemisinin-piperaquine
Sponsors
Liverpool School of Tropical Medicine (LSTM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Children with uncomplicated falciparum malaria confirmed by rapid diagnostic test (RDT) * Axillary temperature ¿ 37.5 °C * Parasite density 2,000-200,000/microliter * Body weight 5.0-24.9 kg * Provision of informed consent by parent or guardian * Intention to return for directly observed treatment and follow-up visits
Exclusion criteria
Exclusion criteria: * Hypersensitivity to the study drug * Signs of severe malaria at screening * Family history of sudden death or of congenital prolongation of the QTc interval * Baseline QTc-interval > 450msec * Known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval * History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia * Any history of cardiac disease, including congenital heart disease or rheumatic heart disease, uncontrolled hypertension, hypertrophic cardiomyopathy, any underlying cardiomyopthy with reduced left ventricular ejection fraction * Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia * Taking medicinal products that are known to prolong the QTc interval * Known renal or hepatic insufficiency * Severe malnutrition * Severe anaemia (haemoglobin <5g/dl) * Mental impairment * Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products * Intent to reside outside of catchment area during the course of the study or likely to be non-compliant with the follow-up schedule, i.e. recent arrivals or known mobile populations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Blood sample for multiple dose pharmacokinetic profile;Efficacy: Malaria blood smear and filter paper samples;Safety: Electrocardiogram;Safety: Haemoglobin;Safety: Adverse events | — |
Countries
Malawi
Contacts
Public ContactDianne J. Terlouw
Malawi-Liverpool-Wellcome Trust Clinical Research Programme / College of Medicine
Outcome results
None listed