School Based Malaria Control in Ugandan Schoolchildren (SBMC)

May 22, 2013 updated by: Faculty of Medicine, Makerere University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

740

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Tororo, Uganda, 256
        • Mulanda Sub-district

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: Joaniter I Nankabirwa, MSc CEB, Makerere University Kampala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (Estimate)

November 1, 2010

Study Record Updates

Last Update Posted (Estimate)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCDC-SBMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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