Pharmacokinetics of Sulfadoxine-pyrimethamine Plus Amodiaquine for Intermittent Preventive Treatment in Children (IPTc)
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborator:
Cheikh Anta Diop University, Senegal
Treatments:
Amodiaquine Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine