School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children
Overview
- Phase
- Phase 3
- Intervention
- Four monthly IPT with dihydroartemisinin Piperaquine (DP)
- Conditions
- Malaria
- Sponsor
- Makerere University
- Enrollment
- 740
- Locations
- 1
- Primary Endpoint
- Risk of Clinical Malaria
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo.
Investigators
Faculty of Medicine
Dr
Makerere University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 6 - 14 years
- •Pupils enrolled at participating school
- •Willingness of the parent/guardian to provide consent
- •Provision of assent by pupil (those above 8 years)
Exclusion Criteria
- •Known allergy or history of adverse reaction to study medications
- •Intention of changing of schools during the follow-up period
- •History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care
Arms & Interventions
Four monthly IPT
IPT give once a school term (every four months)
Intervention: Four monthly IPT with dihydroartemisinin Piperaquine (DP)
Monthly IPT
IPT given every month
Intervention: Monthly IPT using DP
Placebo
No active drug in the placebo
Intervention: Placebo given every month
Outcomes
Primary Outcomes
Risk of Clinical Malaria
Time Frame: 1 year
Fever(temperature greater or equal to 37.5 degrees centigrade or history of fever in past 24 hours) in presence of parasitemia.
Cognitive function tests
Time Frame: 1 year
Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)
Secondary Outcomes
- Risk of parasitemia(1 year)
- Risk of hospital admissions(1 year)
- Risk of adverse events(1 year)
- School performance(1 year)
- Prevalence of anemia(1 year)