Anemia in Children, Malaria,Falciparum
Conditions
Keywords
IPTsc, school, chemoprevention, intermittent preventive treatment, malaria transmission
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.
Interventions
DRUGDihydroartemisinin-Piperaquine
Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).
DRUGChloroquine
Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.
DRUGSulfadoxine-pyrimethamine-amodiaquine
Treatment in Arm 2 (females less than 13 years old and all males).
Sponsors
Liverpool School of Tropical Medicine
Kamuzu University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion 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
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) |
| Number of participants with anemia | 6-8 weeks after the last intervention | World Health Organization age-sex definitions (binary) |
| Rate of clinical malaria | through study completion (approximately 6 months), and 6 months following the intervention | cumulative incidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean hemoglobin concentration | 6-8 weeks after the last intervention | g/dL (continuous) |
| Literacy skills | 6-8 weeks after the last intervention | Early grade reading assessment |
| Math skills | 6-8 weeks after the last intervention | Early grade math assessment |
| Rate of school absenteeism among participants | through study completion (approximately 6 months) | Proportion of days absent among days where attendance is assessed |
| 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 |
| Rate of clinical malaria among children less than 5 years old living in households with study participants | through study completion (approximately 6 months) | cumulative incidence |
Countries
Malawi
Outcome results
None listed