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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329134

Enrollment

Registered

2006-05-24

Start date

2006-07-31

Completion date

2007-05-31

Last updated

2009-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Brief summary

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.

Interventions

DRUGAdministration of quinine sulphate taste-masked pellets

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

Inclusion criteria

* Malaria (falciparium malaria, uncomplicated) * Informed consent

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Clocktime when child has had no fever for minimal 48h (< 37,5°C)	—
Parasitemy	—

Secondary

Measure	Time frame
Plasma concentration of quinine at day 4 between first and second administration	—

Countries

Rwanda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026