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OpenTrials
Completed

NCT Number: NCT00329134

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

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.

Completed

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier De Butare

Butare, Rwanda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malaria (falciparium malaria, uncomplicated)
  • Informed consent

Exclusion criteria

-

Treatment and study plan

Administration of quinine sulphate taste-masked pellets

Drug

Primary outcomes

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

  2. Parasitemy

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 24, 2006
Registry last updated
Apr 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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