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SBMC: School Based Malaria Control in Ugandan Schoolchildren

Sponsor
Makerere University (Other)
Overall Status
Completed
CT.gov ID
NCT01231880
Collaborator
Bill and Melinda Gates Foundation (Other)
740
Enrollment
1
Location
3
Arms
19
Duration (Months)
39
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)
  • Drug: Monthly IPT using DP
  • Drug: Placebo given every month
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
740 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Cognitive function tests [1 year]

      Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)

    Secondary Outcome Measures

    1. Risk of parasitemia [1 year]

      presence of asexual parasites on blood smear

    2. Risk of hospital admissions [1 year]

      Admission of any cause

    3. Risk of adverse events [1 year]

      Any untoward medical occurrence in a participant taking study medication

    4. School performance [1 year]

      Average position in class as reported in the end of the year school report

    5. Prevalence of anemia [1 year]

      Proportion of hemoglobin measurements < 10 g/dL.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mulanda Sub-district Tororo Uganda 256

    Sponsors and Collaborators

    • Makerere University
    • Bill and Melinda Gates Foundation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Faculty of Medicine, Dr, Makerere University
    ClinicalTrials.gov Identifier:
    NCT01231880
    Other Study ID Numbers:
    • MCDC-SBMC
    First Posted:
    Nov 1, 2010
    Last Update Posted:
    May 23, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Faculty of Medicine, Dr, Makerere University
    Malaria
    Additional relevant MeSH terms:
    Malaria
    Piperaquine
    Artenimol

    Study Results

    No Results Posted as of May 23, 2013