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Pharmacokinetics, Efficacy, Gametocyte Carriage, Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment in Pregnant Women

Malaria Clinical Trial

Official title:
An Open-label in Vivo Drug Study to Evaluate the Pharmacokinetics, Therapeutic Efficacy, Gametocyte Carriage and Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment (SP IPT) in Pregnant Women

Clinical Trial Summary

The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine found when given to pregnant women for the prevention of malaria to those found in pregnant women given the same drug with artesunate for the treatment of malaria, and also with those drug levels found in non-pregnant women in other malaria treatment studies.

Clinical Trial Description

Pregnancy increases the risk of malaria progression and complications with up to a 10-fold increase in the malaria case fatality rate in areas of low transmission. Sulfadoxine-pyrimethamine (SP) is used widely in Africa for the systematic intermittent presumptive, or preventive, treatment (IPTp) during the second and third trimester of pregnancy and a national program of IPTp with SP has been implemented recently in Mozambique. There is evidence that the kinetics of several other antimalarial drugs are altered in pregnancy to the extent that doses are not adequate in pregnancy, however no published study has included a pharmacokinetic component to confirm that standard doses of SP are optimal in this vulnerable patient group. This study therefore creates the opportunity to study whether the pharmacokinetic properties of SP are altered by physiological changes that occur during pregnancy. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00380146
Study type Interventional
Source University of Cape Town
Contact
Status Completed
Phase N/A
Start date September 2006
Completion date March 2008
View Details
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