Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203801
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2005-08-29
Brief Title:
Combination Antimalarials in Uncomplicated Malaria
Sponsor:
University of Cape Town
Organization:
University of Cape Town
Study Overview
Official Title:
Open Label Study to Evaluate Combination Anti-malarial Therapyin Terms of Efficacy Prevalence of Gametocyte Carriage and Molecular Markers Associated With Sulfadoxine Pyrimethamine Resistance in Uncomplicated Plasmodium Falciparum
Status:
COMPLETED
Status Verified Date:
2018-10
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 purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine
Detailed Description:
The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria In the South East African Combination Anti-malarial Therapy SEACAT evaluation there will be a comprehensive evaluation of phased introduction of combination anti-malarials CAT in Mozambique Swaziland and South Africa In order to facilitate formulation of an effective regional drug policy and provide a database for decision-making on the implementation of combination therapy it is essential that the in vivo response to CAT in all three countries be investigated An SP therapeutic efficacy study will be conducted according to this modified World Health Organization WHO protocol to guide the selection of CAT After CAT is introduced an in vivo CAT efficacy study will then be conducted to evaluate the efficacy of artesunate plus SP or artemether-lumefantrine in KwaZulu Natal and Limpopo In areas of low intensity malaria transmission the CAT in vivo study results will be compared across sites and with those found at baseline with monotherapy for each site
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