School Based Malaria Control in Ugandan Schoolchildren

Study Overview
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Brief Summary
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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.

Official Title
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School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children

Conditions
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Malaria

Intervention / Treatment
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* Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)
* Drug: Monthly IPT using DP
* Drug: Placebo given every month


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Four monthly IPT<br>IPT give once a school term (every four months) | Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)<br>* Given every 4 months (once a school term)<br>* Other names: Duocortexin;|
| Experimental: Monthly IPT<br>IPT given every month | Drug: Monthly IPT using DP<br>* Given every month<br>* Other names: Duocortexin;|
| Placebo Comparator: Placebo<br>No active drug in the placebo | Drug: Placebo given every month<br>* No active ingredient<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of Clinical Malaria | Fever(temperature greater or equal to 37.5 degrees centigrade or history of fever in past 24 hours) in presence of parasitemia. | 1 year | 
| Cognitive function tests | Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of parasitemia | presence of asexual parasites on blood smear | 1 year | 
| Risk of hospital admissions | Admission of any cause | 1 year | 
| Risk of adverse events | Any untoward medical occurrence in a participant taking study medication | 1 year | 
| School performance | Average position in class as reported in the end of the year school report | 1 year | 
| Prevalence of anemia | Proportion of hemoglobin measurements < 10 g/dL. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria