Antimalarial Dose Justification and Tolerability Study of DHA-Piperaquine in the 5-24 kg Weight Band in Malawi

Not Applicable

• Conditions: Malaria; Paediatrics

• Registration Number: PACTR201303000506302
• Lead Sponsor: iverpool School of Tropical Medicine (LSTM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

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

* 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: Blood sample for multiple dose pharmacokinetic profile;Efficacy: Malaria blood smear and filter paper samples;Safety: Electrocardiogram;Safety: Haemoglobin;Safety: Adverse events