Clinical trial NCT06083688: Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
Official title: Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Malaria,Falciparum
Anemia in Children
Keywords: IPTsc
school
chemoprevention
intermittent preventive treatment
malaria transmission
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
First posted: 2023-10-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Students will be randomized to three arms Arm 1: intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTsc-DP); Arm 2: intermittent preventive treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPTsc-SPAQ); Arm 3 the control arm. Females 13 years and older (likely post-menarche) in Arms 1 and 2 will receive chloroquine alone.
Primary purpose: PREVENTION

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 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.

Detailed description: Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the 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 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.

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

Primary outcomes:
measure: Number of participants with P. falciparum infection
timeFrame: 6-8 weeks after the last intervention
measure: Number of participants with anemia
timeFrame: 6-8 weeks after the last intervention
measure: Rate of clinical malaria
timeFrame: through study completion (approximately 6 months), and 6 months following the intervention
Secondary outcomes:
measure: Mean hemoglobin concentration
timeFrame: 6-8 weeks after the last intervention
measure: Literacy skills
timeFrame: 6-8 weeks after the last intervention
measure: Math skills
timeFrame: 6-8 weeks after the last intervention
measure: Rate of school absenteeism among participants
timeFrame: through study completion (approximately 6 months)
measure: P. falciparum prevalence among children less than 5 years old living in households with study participants
timeFrame: 6-8 weeks after the last intervention
measure: Rate of clinical malaria among children less than 5 years old living in households with study participants
timeFrame: through study completion (approximately 6 months)
Other outcomes:
measure: Total parasite density
timeFrame: 6-8 weeks after the last intervention
Locations:
city: Blantyre
country: Malawi
facility: Malaria Alert Centre
Study officials:
References: