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School Based Malaria Control in Ugandan Schoolchildren (SBMC)

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ClinicalTrials.gov Identifier: NCT01231880
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : May 23, 2013
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University

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

Study Type : Interventional  (Clinical Trial)
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 : February 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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.

  2. Cognitive function tests [ Time Frame: 1 year ]
    Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)


Secondary Outcome Measures :
  1. Risk of parasitemia [ Time Frame: 1 year ]
    presence of asexual parasites on blood smear

  2. Risk of hospital admissions [ Time Frame: 1 year ]
    Admission of any cause

  3. Risk of adverse events [ Time Frame: 1 year ]
    Any untoward medical occurrence in a participant taking study medication

  4. School performance [ Time Frame: 1 year ]
    Average position in class as reported in the end of the year school report

  5. Prevalence of anemia [ Time Frame: 1 year ]
    Proportion of hemoglobin measurements < 10 g/dL.



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Faculty of Medicine, Makerere University:
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents