School Based Malaria Control in Ugandan Schoolchildren

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01231880

Acronym

SBMC

Enrollment

740

Registered

2010-11-01

Start date

2011-02-28

Completion date

2012-09-30

Last updated

2013-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Malaria

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.

Interventions

DRUGFour monthly IPT with dihydroartemisinin Piperaquine (DP)

Given every 4 months (once a school term)

DRUGMonthly IPT using DP

Given every month

DRUGPlacebo given every month

No active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026