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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00329134 |
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Date of registration:
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22/05/2006 |
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Primary sponsor: |
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Public title:
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Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
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Scientific title:
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Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00329134 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Rwanda
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Contacts
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Name:
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Luc Van Bortel, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Ghent |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Malaria (falciparium malaria, uncomplicated)
- Informed consent
Exclusion Criteria:
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Age minimum:
6 Months
Age maximum:
59 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: Administration of quinine sulphate taste-masked pellets
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Primary Outcome(s)
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Clocktime when child has had no fever for minimal 48h (< 37,5°C)
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Parasitemy
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Secondary Outcome(s)
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Plasma concentration of quinine at day 4 between first and second administration
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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