School Based Malaria Control in Ugandan Schoolchildren

Phase 3

Completed

• Conditions: Malaria
• Interventions: Drug: Monthly IPT using DP; Drug: Placebo given every month; Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)

• Registration Number: NCT01231880
• Lead Sponsor: Makerere University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-01
• Study Start: 2011-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monthly IPT	Monthly IPT using DP	IPT given every month
Placebo	Placebo given every month	No active drug in the placebo
Four monthly IPT	Four monthly IPT with dihydroartemisinin Piperaquine (DP)	IPT give once a school term (every four months)

Primary Outcome Measures

Name	Time	Method
Risk of Clinical Malaria	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	1 year	Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mulanda Sub-district; 🇺🇬 Tororo, Uganda