Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
740 participants
INTERVENTIONAL
2011-02-28
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Four monthly IPT
IPT give once a school term (every four months)
Four monthly IPT with dihydroartemisinin Piperaquine (DP)
Given every 4 months (once a school term)
Monthly IPT
IPT given every month
Monthly IPT using DP
Given every month
Placebo
No active drug in the placebo
Placebo given every month
No active ingredient
Interventions
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Four monthly IPT with dihydroartemisinin Piperaquine (DP)
Given every 4 months (once a school term)
Monthly IPT using DP
Given every month
Placebo given every month
No active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pupils enrolled at participating school
* Willingness of the parent/guardian to provide consent
* Provision of assent by pupil (those above 8 years)
Exclusion Criteria
* 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
6 Years
14 Years
ALL
Yes
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Makerere University
OTHER
Responsible Party
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Faculty of Medicine
Dr
Principal Investigators
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Joaniter I Nankabirwa, MSc CEB
Role: PRINCIPAL_INVESTIGATOR
Makerere University Kampala
Locations
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Mulanda Sub-district
Tororo, Uganda, Uganda
Countries
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References
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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.
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.
Other Identifiers
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MCDC-SBMC
Identifier Type: -
Identifier Source: org_study_id
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