Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344006
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2006-06-22
Brief Title:
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Double Dummy Study Comparing the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Artemether-lumefantrine in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children and Adolescents in Africa
Status:
COMPLETED
Status Verified Date:
2016-12
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:
Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa and by the UKs Medicines and Healthcare products Regulatory Agency
CDA is a combination of chlorproguanil dapsone and artesunate being developed in a public-private partnership with the Medicines for Malaria Venture MMV World Health Organisation WHO-TDR and academic partners from the London School of Hygiene and Tropical Medicine University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P falciparum malaria
The combination of chlorproguanil-dapsone-artesunate CDA is being developed to supersede chlorproguanil-dapsone for the same indication but the addition of an artemisinin derivative artesunate should provide additional population benefits over chlorproguanil-dapsone alone The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the Pfalciparum lifecycle The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of Pfalciparum
Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P falciparum malaria This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days The key secondary objectives will compare the Parasite Clearance Times PCT and the Fever Clearance Times FCT between CDA and artemether-lumefantrine
CDA is a combination of chlorproguanil dapsone and artesunate being developed in a public-private partnership with the Medicines for Malaria Venture MMV World Health Organisation WHO-TDR and academic partners from the London School of Hygiene and Tropical Medicine University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P falciparum malaria
The combination of chlorproguanil-dapsone-artesunate CDA is being developed to supersede chlorproguanil-dapsone for the same indication but the addition of an artemisinin derivative artesunate should provide additional population benefits over chlorproguanil-dapsone alone The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the Pfalciparum lifecycle The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of Pfalciparum
Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P falciparum malaria This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days The key secondary objectives will compare the Parasite Clearance Times PCT and the Fever Clearance Times FCT between CDA and artemether-lumefantrine
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