Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203814
Status:
COMPLETED
Last Update Posted:
2006-11-16
First Post:
2005-09-13
Brief Title:
A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
Sponsor:
University of Cape Town
Organization:
University of Cape Town
Study Overview
Official Title:
Open-Label Randomised Parallel Group in Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy CAT Artesunate and Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone in Terms of Therapeutic Efficacy Prevalence of Gametocyte Carriage and Prevalence of Molecular Markers Associated With SP Resistance In Uncomplicated Plasmodium Falciparum Infections
Status:
COMPLETED
Status Verified Date:
2005-08
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 purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria
Detailed Description:
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria In order to facilitate formulation of effective regional drug policies and to provide a database for decision-making on the implementation of combination therapy CAT it is essential that the in vivo response to CAT be investigated In the South East African Combination Anti-malarial Therapy SEACAT evaluation there is a comprehensive evaluation of the phased introduction of combination anti-malarial therapy in Mozambique As a component of this evaluation in selected Mozambique sites where intensity of malaria transmission is high a direct parallel group comparison of monotherapy SP with CAT artesunate plus SP will be conducted according to this protocol
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