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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:
ClinicalTrials.gov Identifier:
NCT00329134
First Posted: May 24, 2006
Last Update Posted: April 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Ghent
  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
Intervention Model: Single Group Assignment
Masking: None (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)
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Malaria (falciparium malaria, uncomplicated)
  • Informed consent

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Jean Paul Remon, University Ghent
ClinicalTrials.gov Identifier: NCT00329134     History of Changes
Other Study ID Numbers: 2006/177
First Submitted: May 22, 2006
First Posted: May 24, 2006
Last Update Posted: April 17, 2009
Last Verified: April 2009

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