Malaria,Falciparum, Anemia in Children
Conditions
Keywords
malaria, school, chemoprevention, preventive treatment, education, cognitive function, adolescent, hemoglobin
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).
Interventions
DRUGChloroquine
Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
DRUGDihydroartemisinin-Piperaquine
Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
Sponsors
Kamuzu University of Health Sciences
Doris Duke Charitable Foundation
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Laboratory technicians processing samples will be blinded to participant's study arm.
Intervention model description
Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
Students (enrolled in the primary intervention) * Previously enrolled in NCT05244954 * 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 Younger children in participant households (enrolled in the Household Prevalence survey) * Slept in the household for most nights in the last month * Age 6-59 months * Parent/guardian available to provide written informed consent
Exclusion criteria
Students (enrolled in the primary intervention) * 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 * Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole * Epilepsy * Psoriasis Household members (enrolled in the Household Prevalence survey) * Household with more than one school-age child enrolled in the study * Current evidence of severe malaria or danger signs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with P. falciparum infection | 6-8 weeks after the last intervention | detected by polymerase chain reaction (PCR, binary) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with anemia | 6-8 weeks after the last intervention | World Health Organization age-sex definitions (binary) |
| Total parasite density | 6-8 weeks after the last intervention | log transformed (continuous) |
| Rate of clinical malaria | through study completions, approximately 6 months | cumulative incidence |
| P. falciparum prevalence among children less than 5 years old living in households with study participants | 6-8 weeks after the last intervention | detected by PCR |
| Mean hemoglobin concentration | 6-8 weeks after the last intervention | g/dL (continuous) |
| selective attention | 6-8 weeks after the last intervention | selective attention test score (continuous) |
| Literacy skills | 6-8 weeks after the last intervention | onetest reading test score (continuous) |
| Math skills | 6-8 weeks after the last intervention | onetest math score (continuous) |
| sustained attention | 6-8 weeks after the last intervention | code transmission test score (continuous) |
Countries
Malawi
Outcome results
None listed