Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05244954
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2022-01-11
Brief Title:
Comparing Chemoprevention Approaches for School-based Malaria Control
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P Falciparum Infection and Transmission
Status:
COMPLETED
Status Verified Date:
2022-11
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:
This is an individually randomized controlled single blind three arm clinical trial of malaria chemoprevention strategies Arm 1 Intermittent screening and treatment IST - students will receive treatment if they have a positive high sensitivity rapid diagnostic test RDT Arm 2 Intermittent preventive treatment IPT - all students will receive treatment Arm 3 Control - students will receive standard of care no preventive treatment Outcomes include P falciparum infection and parasite density gametocyte carriage and gametocyte density anemia cognitive function and educational testing as well as infection prevalence in students households to assess the impact on transmission
Detailed Description:
Students will be enrolled in a single primary school in Machinga District Malawi The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission Students in the IPT are and those that test positive in the IST arm will be treatment with dihydroartemisinin-piperaquine DP females less than 10 years old and all males or chloroquine females 10 years old or older
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None