Active — Not RecruitingPhase 4

Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

Malawi1,000 participantsStarted 2024-10-14

Plain-language 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.

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with P. falciparum infection

Timeframe: 6-8 weeks after the last intervention

Number of participants with anemia

Timeframe: 6-8 weeks after the last intervention

Rate of clinical malaria

Timeframe: through study completion (approximately 6 months), and 6 months following the intervention

Trial details

NCT IDNCT06083688

SponsorLiverpool School of Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Malaria,Falciparum trials

Plain-language summary

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with P. falciparum infection

Timeframe: 6-8 weeks after the last intervention

Number of participants with anemia

Timeframe: 6-8 weeks after the last intervention

Rate of clinical malaria

Timeframe: through study completion (approximately 6 months), and 6 months following the intervention