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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.
Sponsor:
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00329134
First received: May 22, 2006
Last updated: April 16, 2009
Last verified: April 2009
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Malaria (falciparium malaria, uncomplicated)
  • Informed consent

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329134

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

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jean Paul Remon, University Ghent
ClinicalTrials.gov Identifier: NCT00329134     History of Changes
Other Study ID Numbers: 2006/177
Study First Received: May 22, 2006
Last Updated: April 16, 2009
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on May 22, 2013