Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599593
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
Brief Summary:
In the Sahel the malaria and malnutrition seasons overlap during the rainy season from approximately July through October Malaria transmission increases due to the rain and collection of standing water and malnutrition risk increases because this period is the growing season leading up to the annual harvest in November Seasonal malaria chemoprevention SMC is an antimalarial intervention that involves monthly distribution of sulfadoxine-pyrimethamine SP and amodiaquine AQ to children aged 3-59 months during the high malaria transmission season SMC is distributed to millions of children annually in 13 countries in the Sahel including Burkina Faso Although SMC distribution is highly effective against clinical malaria in children malaria remains a major cause of childhood mortality and morbidity in Burkina Faso The SMC platform which involves monthly door-to-door delivery of SP-AQ is an attractive platform for delivery of additional interventions that may augment child health during this vulnerable season Malaria and malnutrition co-occur in children and communities and interventions for one may affect the other For example previous work by our group and others has shown that antimalarial treatments may improve weight gain in children with malnutrition Here we propose a pilot trial designed to evaluate how the SMC platform may be leveraged to deliver co-interventions with SMC that may augment its efficacy and reduce the incidence of malaria and malnutrition We anticipate that the results of this study will provide formative data for the development and implementation of a full-scale study evaluating the effects of integration of nutritional interventions on the SMC platform We anticipate that such a strategy may provide optimal protection for children during the most vulnerable period of the year by delivering interventions monthly on an existing platform that directly reaches millions of children each month
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