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

University Ghent

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: Administration of quinine sulphate taste-masked pellets

Study type: Interventional

Funder types: Other

Identifiers

NCT00329134

2006/177

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Malaria (falciparium malaria, uncomplicated)
• Informed consent

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)