Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399074
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2006-11-13
Brief Title:
Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia
Sponsor:
Makerere University
Organization:
Makerere University
Study Overview
Official Title:
Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia
Status:
COMPLETED
Status Verified Date:
2009-07
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:
Malaria is fatal and increases the risk of death among children with sickle cell anemia Chemoprophylaxis significantly improves quality of life in these children In Uganda Chloroquine is the drug of choice for prophylaxis and yet its effectiveness is limited due to high levels of resistance throughout the country Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia
Hypothesis Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia
Hypothesis Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia
Detailed Description:
Malaria is fatal and increases the risk of death among children with sickle cell anemia Chemoprophylaxis significantly improves quality of life in these children In Uganda Chloroquine is the drug of choice for prophylaxis and yet its effectiveness is limited due to high levels of resistance throughout the country Intermittent presumptive treatment with sulfadoxine - pyrimethamine a new approach to malaria prevention has shown great potential in reducing incidence of malaria and anemia among high risk groups such as pregnant women and infants However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces incidence of malaria among high risk group such as children with sickle cell anaemia
We calculated a sample size of 110 patients in each group for a power of 95 assuming that the incidence of malaria in children receiving weekly chloroquine will be 036 and those receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 016 according to schellenberg et al
We calculated a sample size of 110 patients in each group for a power of 95 assuming that the incidence of malaria in children receiving weekly chloroquine will be 036 and those receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 016 according to schellenberg et al
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