NCT01328990|CompletedPhase 1/2
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Sponsor study identifier
interventional
150
1 country
1
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)The aim of the study is to determine the pharmacokinetic profile of sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) when used for seasonal Intermittent Preventive Treatment (IPT) to prevent malaria in children aged 3 to 59 months in Lamarame, NDoffane District, Senegal. Several studies have shown that seasonal IPT in children can provide a high degree of protection against clinical malaria. SP+AQ is the most effective regimen. However little is known about the pharmacokinetics of amodiaquine and sulfadoxine-pyrimethamine in children. The purpose of this study is to determine the pharmacokinetics profile of SP+AQ when used for IPT in Senegalese children. 150 children aged 3 to 59 months will be enrolled in November. They will receive a therapeutic dose of sulfadoxine-pyrimethamine and amodiaquine, and will be followed up for 30 days. Four finger prick blood samples will be taken from each child for PK analysis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 4, 2011
Actual (reported)April 5, 2011
Actual (reported)July 2011
Actual (reported)July 2011
Actual (reported)Concentration of sulfadoxine, pyrimethamine, and desethylamodiaquine
Concentration of the drugs will be measured at four time points.
28 days
Tolerability
28 days
one dose of sulfadoxine-pyrimethamine 25/1.25 mg/kg plus three daily doses of amodiaquine, 10 mg/kg/day
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Grouped treatment entry
sulfadoxine-pyrimethamine plus amodiaquine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversite Chiekh Anta Diop
Dakar, Senegal
Badara Cisse, PhD
Universite Chiekh Anta Diop
Paul Milligan, PhD
London School of Hygiene and Tropical Medicine
150 participants (actual enrollment reported by the registry).
First Submitted
April 4, 2011
First Posted
April 5, 2011
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
September 19, 2011
Record last verified: 2011-09
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Source: ClinicalTrials.gov.
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