Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT05980156
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2023-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Chemoprevention Drugs for School-based Malaria Control
Sponsor:
University of Maryland, Baltimore
Organization:
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: Phase 2 Comparing Drug Regimens
Status:
COMPLETED
Status Verified Date:
2023-08
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 preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence in young children sleeping student's households to assess the impact on transmission.
Detailed Description:
Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: