Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria

University Ghent56 enrolled

Overview

No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4 parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is administered to the child. At this moment, quinine sulphate pellets are developed. These pellets enable an adequate dosing according to the body weight. 56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body weight.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malaria

Interventions

Administration of quinine sulphate taste-masked pelletsDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Malaria (falciparium malaria, uncomplicated) * Informed consent Exclusion Criteria: \-

Locations (1)

Centre Hospitalier De Butare

Butare, Rwanda

Outcomes

Primary Outcomes

Clocktime when child has had no fever for minimal 48h (< 37,5°C)

Parasitemy

Secondary Outcomes

Plasma concentration of quinine at day 4 between first and second administration

Data from ClinicalTrials.gov

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