Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460369
Status:
COMPLETED
Last Update Posted:
2008-04-14
First Post:
2007-04-12
Brief Title:
Treatment of Uncomplicated Malaria in Benin
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria an Open Randomized Study
Status:
COMPLETED
Status Verified Date:
2008-04
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:
Malaria is a life-threatening disease especially in small children A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place In the past few years the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine SP There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies ACT artemether-lumefantrine and the amodiaquine-artesunate coformulation ACT will be unsupervised
The primary endpoint is an effectiveness comparison PCR corrected at day 28 Secondary outcomes are effectiveness comparisons PCR corrected at day 14 and 42 and a study on the relationships between ACT PK data day 3 and outcome
Expected total enrollment 225 patients
Study start April 2007 expected completion December 2007
The primary endpoint is an effectiveness comparison PCR corrected at day 28 Secondary outcomes are effectiveness comparisons PCR corrected at day 14 and 42 and a study on the relationships between ACT PK data day 3 and outcome
Expected total enrollment 225 patients
Study start April 2007 expected completion December 2007
Detailed Description:
None
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