Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354380
Status:
COMPLETED
Last Update Posted:
2006-10-24
First Post:
2006-07-19
Brief Title:
Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso a Pilot Study
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-09
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 primary objective of this trial is to study the safety of the combination methylene blue MB-artesunate AS and MB-amodiaquine AQ in treating malaria among children compared to the safety of an AS-AQ regimen The secondary objective is to investigate the efficacy of MB-AS and MB-AQ
Detailed Description:
Objectives The primary objective of this trial is to study the safety of the combination methylene blue MB-artesunate AS and MB-amodiaquine AQ given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ
Population Children aged 6-10 years with uncomplicated malaria from Nouna town
Sample size N 180 n60 for each group
Treatment The participants in the MB-AS group will receive orally twice daily 9mgkg MB combined with once daily 4mgkg AS over 3 days The participants in the MB-AQ group will receive orally twice daily 9mgkg MB combined with once daily 10mgkg AQ over 3 days The participants of the comparator group will receive a 3 day regimen of once daily oral AS 4mgkg combined with once daily AQ 10mgkg
Endpoints The primary endpoint is the number of adverse events AE after drug intake until day 28 Secondary endpoints are the number of serious adverse events SAE adequate clinical and parasitological response ACPR rate on day 28 clinical and parasitological failure rates on day 3 7 14 and 28 changes in haematocrit until day 28 and fever and parasite clearance time
Population Children aged 6-10 years with uncomplicated malaria from Nouna town
Sample size N 180 n60 for each group
Treatment The participants in the MB-AS group will receive orally twice daily 9mgkg MB combined with once daily 4mgkg AS over 3 days The participants in the MB-AQ group will receive orally twice daily 9mgkg MB combined with once daily 10mgkg AQ over 3 days The participants of the comparator group will receive a 3 day regimen of once daily oral AS 4mgkg combined with once daily AQ 10mgkg
Endpoints The primary endpoint is the number of adverse events AE after drug intake until day 28 Secondary endpoints are the number of serious adverse events SAE adequate clinical and parasitological response ACPR rate on day 28 clinical and parasitological failure rates on day 3 7 14 and 28 changes in haematocrit until day 28 and fever and parasite clearance time
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