Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461578
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-04-16
Brief Title:
Tolerability and Efficacy of CDA Compared to AQSP for the Treatment of PFalciparum Malaria in Rwandan Children
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Open Study on the Tolerability and Efficacy of the Combination Chlorproguanil-DapsoneArtesunate Compared to AmodiaquineSulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria in Rwandan Children
Status:
COMPLETED
Status Verified Date:
2007-04
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:
In 2005-2006 a clinical trial was carried out to test safety tolerability and efficacy of the combination chlorproguanil-dapsoneartesunate CDA 800 children aged 12-59 months with uncomplicated P falciparum malaria randomly allocated to AQSP or CDA were followed up until day 28 after treatment Adverse events clinical and parasitological outcomes were recorded
Detailed Description:
Between 2001 and 2006 as an interim strategy Rwanda chose amodiaquine sulfadoxine-pyrimethamine AQSP as the first line anti-malaria treatment Although the clinical response to this combination was relatively good in 2001 since then its efficacy has steadily declined in 2002 the proportion of successful treatment recorded at 28 days and PCR-unadjusted was 83 Rwagacondo et al 2003 and in 2003 it was 74 Karema et al 2006 Different artemisinin-based combination treatments ACTs such as amodiaquineartesunate AQAS dihydroartemisinin-piperaquine DHAPPQ and artemether-lumefantrine ALN have been tested in the past few years as possible alternatives to AQSP Fanello et al 2006 Karema et al 2006
Chlorproguanil-dapsone also known asLapDap is an antifolate combination similar to sulfadoxinepyrimethamine SP but for two important features 1 it is rapidly eliminated and therefore exerts less selective pressure for resistance-conferring parasite mutations than does SP Winstanley et al 1997 Nzila et al 2000b and 2 it is active against the SP-resistant forms of the parasite that are found in Africa Mutabingwa et al 2001ab Kublin et al 2002 Moreover a pediatric course of treatment of LapDap is estimated to cost 015 Mutabingwa et al 2001b making it orders of magnitude less expensive than any marketed antimalarial drug other than chloroquine and SP
In 2005-2006 a clinical trial was carried out to test safety tolerability and efficacy of the combination chlorproguanil-dapsoneartesunate CDA 800 children aged 12-59 months with uncomplicated P falciparum malaria randomly allocated to AQSP or CDA were followed up until day 28 after treatment Adverse events clinical and parasitological outcomes were recorded
Based on the results of all trials carried out by the NMCP The Rwandan Ministry of Health has now changed the first line to artemether-lumefantrine ALN Coartem The drug arrived in the country in October 2006
Chlorproguanil-dapsone also known asLapDap is an antifolate combination similar to sulfadoxinepyrimethamine SP but for two important features 1 it is rapidly eliminated and therefore exerts less selective pressure for resistance-conferring parasite mutations than does SP Winstanley et al 1997 Nzila et al 2000b and 2 it is active against the SP-resistant forms of the parasite that are found in Africa Mutabingwa et al 2001ab Kublin et al 2002 Moreover a pediatric course of treatment of LapDap is estimated to cost 015 Mutabingwa et al 2001b making it orders of magnitude less expensive than any marketed antimalarial drug other than chloroquine and SP
In 2005-2006 a clinical trial was carried out to test safety tolerability and efficacy of the combination chlorproguanil-dapsoneartesunate CDA 800 children aged 12-59 months with uncomplicated P falciparum malaria randomly allocated to AQSP or CDA were followed up until day 28 after treatment Adverse events clinical and parasitological outcomes were recorded
Based on the results of all trials carried out by the NMCP The Rwandan Ministry of Health has now changed the first line to artemether-lumefantrine ALN Coartem The drug arrived in the country in October 2006
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