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

This study has been completed.
Information provided by:
University Ghent Identifier:
First received: May 22, 2006
Last updated: April 16, 2009
Last verified: April 2009

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.

Condition Intervention Phase
Drug: Administration of quinine sulphate taste-masked pellets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria

Resource links provided by NLM:

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Clocktime when child has had no fever for minimal 48h (< 37,5°C)
  • Parasitemy

Secondary Outcome Measures:
  • Plasma concentration of quinine at day 4 between first and second administration

Estimated Enrollment: 56
Study Start Date: July 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Malaria (falciparium malaria, uncomplicated)
  • Informed consent

Exclusion Criteria:

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Please refer to this study by its identifier: NCT00329134

Centre Hospitalier De Butare
Butare, Rwanda
Sponsors and Collaborators
University Ghent
Principal Investigator: Luc Van Bortel, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Jean Paul Remon, University Ghent Identifier: NCT00329134     History of Changes
Other Study ID Numbers: 2006/177
Study First Received: May 22, 2006
Last Updated: April 16, 2009

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Sensory System Agents processed this record on May 25, 2017