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Completed
NCT06083688
Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
Conditions: Malaria,Falciparum, Anemia in Children
Sex: All
Ages: 6 Months – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 788
Sponsor: Liverpool School of Tropical Medicine
Location: Malaria Alert Centre Blantyre
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 amodiaquine (AQ) (IPT-SPAQ). 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 and disease incidence in young children sleeping student's households to assess the impact on transmission.
Eligibility Criteria
Student Inclusion Criteria:
* Currently enrolled in the study school
* Plan to attend the study school for the remainder of the school year
* Parent/guardian available to provide written informed consent
Student Exclusion Criteria:
* Current evidence of severe malaria or danger signs
* Known adverse reaction to the study drugs
* History of cardiac problems or fainting
* Taking medications known to prolong QT
* Family history of prolonged QT
* History of epilepsy or psoriasis
* Taking cotrimoxazole for long-term prophylaxis
Younger child Inclusion Criteria
* Slept in the household for most nights in the last month
* Age 6-59 months
* Parent/guardian available to provide written informed consent
Younger child Exclusion Criteria
\- Current evidence of severe malaria or danger signs
Source: ClinicalTrials.gov (NCT06083688). StuddyBuddy aggregates publicly available trial information.