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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Makerere University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Dihydroartemisinin
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014