Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380146
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2006-09-22
Brief Title:
Pharmacokinetics Efficacy Gametocyte Carriage Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment in Pregnant Women
Sponsor:
Professor Karen I Barnes
Organization:
University of Cape Town
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None