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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014