Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137553
Status:
COMPLETED
Last Update Posted:
2010-03-16
First Post:
2005-08-28
Brief Title:
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau
Status:
COMPLETED
Status Verified Date:
2010-03
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:
Children participating in a study evaluating the efficacy of chloroquine and amodiaquine for the treatment of malaria will if getting malaria during follow-up be re-treated with sulfadoxine-pyrimethamine SP in accordance with the recommendations of the National Malaria Programme
To compare the actual efficacy of SP with that in 1995 - 1996 we the investigators of the Bandim Health Project will visit these children once a week for 5 weeks A finger prick blood sample will be collected for a malaria test
Children with malaria during follow-up will be treated according to the guidelines of the Bandim Health Centre
To compare the actual efficacy of SP with that in 1995 - 1996 we the investigators of the Bandim Health Project will visit these children once a week for 5 weeks A finger prick blood sample will be collected for a malaria test
Children with malaria during follow-up will be treated according to the guidelines of the Bandim Health Centre
Detailed Description:
The Bandim Health Project studies the efficacy of different treatment regimens for malaria in children If the included children during follow-up get malaria again they are according to the recommendations of the National Malaria Programme treated with sulfadoxine-pyrimethamine SP
In 1995 - 1996 the efficacy of this re-treatment regimen was evaluated in the same area
To evaluate if treatment with SP is still efficient we want to follow children included in a study comparing treatment with chloroquine and amodiaquine having recrudescent malaria for 35 days following the re-treatment with SP
Children with reappearing parasitaemia will be treated with SP If accepting to participate in this study the children will be visited once a week and a capillary blood sample will be drawn The blood sample taken on the day of reappearing parasitaemia in the chloroquineamodiaquine study will be used as the day 0 blood sample in the SP-study
If the child gets malaria during the follow-up he will be treated according to the guidelines of the Bandim Health Centre All treatment during follow-up will be free
In 1995 - 1996 the efficacy of this re-treatment regimen was evaluated in the same area
To evaluate if treatment with SP is still efficient we want to follow children included in a study comparing treatment with chloroquine and amodiaquine having recrudescent malaria for 35 days following the re-treatment with SP
Children with reappearing parasitaemia will be treated with SP If accepting to participate in this study the children will be visited once a week and a capillary blood sample will be drawn The blood sample taken on the day of reappearing parasitaemia in the chloroquineamodiaquine study will be used as the day 0 blood sample in the SP-study
If the child gets malaria during the follow-up he will be treated according to the guidelines of the Bandim Health Centre All treatment during follow-up will be free
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