Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203736
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 Drug Study With Single and Parallel Group Components to Evaluate Combination Antimalarial Therapy for Efficacy Gametocyte Carriage and 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 compare the efficacy of sulfadoxine-pyrimethamine plus artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of uncomplicated malaria
Detailed Description:
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to malaria control In the South East African Combination Anti-malarial Therapy SEACAT evaluation there is an evaluation of the phased introduction of combination anti-malarial therapy CAT in Mozambique Swaziland and South Africa In order to facilitate formulation of effective regional drug policy and provide a database for decision-making on the implementation of CAT it is essential that the in vivo response to CAT be investigated This will be achieved through the SEACAT 01 protocol which is a component of the SEACAT evaluation described in another file on this website However in selected Mozambique sites where the intensity of malaria transmission is high a direct parallel group comparison of monotherapy SP with CAT artesunate AS plus SP will be conducted according to a specific amendment Amendment 4 to the SEACAT 01 protocol Amendment 4 is presented in this separate file on the website for clarity
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