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School Based Malaria Control in Ugandan Schoolchildren (SBMC)

Primary Purpose

Malaria

Status
Completed
Phase
Phase 3
Locations
Uganda
Study Type
Interventional
Intervention
Four monthly IPT with dihydroartemisinin Piperaquine (DP)
Monthly IPT using DP
Placebo given every month
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mulanda Sub-district

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Four monthly IPT

Monthly IPT

Placebo

Arm Description

IPT give once a school term (every four months)

IPT given every month

No active drug in the placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2010
Last Updated
May 22, 2013
Sponsor
Makerere University
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01231880
Brief Title
School Based Malaria Control in Ugandan Schoolchildren
Acronym
SBMC
Official Title
School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makerere University
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
740 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Four monthly IPT
Arm Type
Experimental
Arm Description
IPT give once a school term (every four months)
Arm Title
Monthly IPT
Arm Type
Experimental
Arm Description
IPT given every month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No active drug in the placebo
Intervention Type
Drug
Intervention Name(s)
Four monthly IPT with dihydroartemisinin Piperaquine (DP)
Other Intervention Name(s)
Duocortexin
Intervention Description
Given every 4 months (once a school term)
Intervention Type
Drug
Intervention Name(s)
Monthly IPT using DP
Other Intervention Name(s)
Duocortexin
Intervention Description
Given every month
Intervention Type
Drug
Intervention Name(s)
Placebo given every month
Other Intervention Name(s)
Placebo
Intervention Description
No active ingredient
Primary Outcome Measure Information:
Title
Risk of Clinical Malaria
Description
Fever(temperature greater or equal to 37.5 degrees centigrade or history of fever in past 24 hours) in presence of parasitemia.
Time Frame
1 year
Title
Cognitive function tests
Description
Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Risk of parasitemia
Description
presence of asexual parasites on blood smear
Time Frame
1 year
Title
Risk of hospital admissions
Description
Admission of any cause
Time Frame
1 year
Title
Risk of adverse events
Description
Any untoward medical occurrence in a participant taking study medication
Time Frame
1 year
Title
School performance
Description
Average position in class as reported in the end of the year school report
Time Frame
1 year
Title
Prevalence of anemia
Description
Proportion of hemoglobin measurements < 10 g/dL.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaniter I Nankabirwa, MSc CEB
Organizational Affiliation
Makerere University Kampala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulanda Sub-district
City
Tororo
ZIP/Postal Code
256
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
27401569
Citation
Nankabirwa JI, Conrad MD, Legac J, Tukwasibwe S, Tumwebaze P, Wandera B, Brooker SJ, Staedke SG, Kamya MR, Nsobya SL, Dorsey G, Rosenthal PJ. Intermittent Preventive Treatment with Dihydroartemisinin-Piperaquine in Ugandan Schoolchildren Selects for Plasmodium falciparum Transporter Polymorphisms That Modify Drug Sensitivity. Antimicrob Agents Chemother. 2016 Sep 23;60(10):5649-54. doi: 10.1128/AAC.00920-16. Print 2016 Oct.
Results Reference
derived
PubMed Identifier
24621953
Citation
Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.
Results Reference
derived

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School Based Malaria Control in Ugandan Schoolchildren

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