Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371735
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2006-09-01
Brief Title:
Chlorproguanil-Dapsone-Artesunate CDA Versus Chlorproguanil-Dapsone LAPDAP For Uncomplicated Malaria
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Study to Compare the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Chlorproguanil-dapsone in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children Adolescents and Adults 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:
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 HCl CPG and dapsone DDS as chlorproguanil-dapsone has already been shown to be efficacious against Pfalciparum in adults and children in Sub-Sahara Africa The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study and reduce the chance of any parasites escaping treatment over the 3-day course The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of Pfalciparum although it will not be possible to demonstrate this in a clinical trial One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite gametocytes which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use including the spread of any parasites resistant to the partner drug
The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone and collect supporting safety data This will be a multi-centre double-blind double-dummy randomised trial in children adolescents and adults with chlorproguanil-dapsone as a comparator
The combination of chlorproguanil HCl CPG and dapsone DDS as chlorproguanil-dapsone has already been shown to be efficacious against Pfalciparum in adults and children in Sub-Sahara Africa The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study and reduce the chance of any parasites escaping treatment over the 3-day course The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of Pfalciparum although it will not be possible to demonstrate this in a clinical trial One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite gametocytes which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use including the spread of any parasites resistant to the partner drug
The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone and collect supporting safety data This will be a multi-centre double-blind double-dummy randomised trial in children adolescents and adults with chlorproguanil-dapsone as a comparator
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