Malaria Alert Centre
Blantyre, Malawi
NCT Number: NCT06083688
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.
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Notify Me6 month and older
All sexes
Interventional
Phase 4
Blantyre, Malawi
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Student Inclusion Criteria:
Student Exclusion Criteria:
Younger child Inclusion Criteria
Younger child Exclusion Criteria
Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).
Other names: DP, D-Artepp, DuoCotecxin, Artekin, Eurartesim, Ridmal
Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.
Other names: Aralen, Hydroxychloroquine, Lariago
Treatment in Arm 2 (females less than 13 years old and all males).
Other names: SPAQ, SPAQ-Co
Time frame: 6-8 weeks after the last intervention
detected by polymerase chain reaction (PCR, binary)
Time frame: 6-8 weeks after the last intervention
World Health Organization age-sex definitions (binary)
Time frame: through study completion (approximately 6 months), and 6 months following the intervention
cumulative incidence
Time frame: 6-8 weeks after the last intervention
g/dL (continuous)
Time frame: 6-8 weeks after the last intervention
Early grade reading assessment
Time frame: 6-8 weeks after the last intervention
Early grade math assessment
Time frame: through study completion (approximately 6 months)
Proportion of days absent among days where attendance is assessed
Time frame: 6-8 weeks after the last intervention
detected by PCR
Time frame: through study completion (approximately 6 months)
cumulative incidence
Time frame: 6-8 weeks after the last intervention
log transformed (continuous)
Liverpool School of Tropical Medicine
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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