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School Based Malaria Control in Ugandan Schoolchildren (SBMC)

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University
ClinicalTrials.gov Identifier:
NCT01231880
First received: October 29, 2010
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Malaria
 Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)
Drug: Monthly IPT using DP
Drug: Placebo given every month
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Risk of Clinical Malaria [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)


Secondary Outcome Measures:
  • Risk of parasitemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    presence of asexual parasites on blood smear

  • Risk of hospital admissions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Admission of any cause

  • Risk of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Any untoward medical occurrence in a participant taking study medication

  • School performance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Average position in class as reported in the end of the year school report

  • Prevalence of anemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Proportion of hemoglobin measurements < 10 g/dL.


Enrollment: 740
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Duocortexin
Experimental: Monthly IPT
IPT given every month
 Drug: Monthly IPT using DP
Given every month
Other Name: Duocortexin
Placebo Comparator: Placebo
No active drug in the placebo
 Drug: Placebo given every month
No active ingredient
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231880

Locations
Uganda
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
  More Information

No publications provided

Responsible Party: Faculty of Medicine, Dr, Makerere University
ClinicalTrials.gov Identifier: NCT01231880     History of Changes
Other Study ID Numbers: MCDC-SBMC
Study First Received: October 29, 2010
Last Updated: May 22, 2013
Health Authority: Uganda: Uganda National Council of Science and Technology

Keywords provided by Makerere University:
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Dihydroquinghaosu
Piperaquine
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013