School Based Malaria Control in Ugandan Schoolchildren

NCT ID: NCT01231880

Last Updated: 2013-05-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Four monthly IPT

IPT give once a school term (every four months)

Group Type EXPERIMENTAL

Four monthly IPT with dihydroartemisinin Piperaquine (DP)

Intervention Type DRUG

Given every 4 months (once a school term)

Monthly IPT

IPT given every month

Group Type EXPERIMENTAL

Monthly IPT using DP

Intervention Type DRUG

Given every month

Placebo

No active drug in the placebo

Group Type PLACEBO_COMPARATOR

Placebo given every month

Intervention Type DRUG

No active ingredient

Interventions

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Four monthly IPT with dihydroartemisinin Piperaquine (DP)

Given every 4 months (once a school term)

Intervention Type DRUG

Monthly IPT using DP

Given every month

Intervention Type DRUG

Placebo given every month

No active ingredient

Intervention Type DRUG

Other Intervention Names

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Duocortexin Duocortexin Placebo

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Medicine

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Uganda

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.

Reference Type DERIVED
PMID: 27401569 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24621953 (View on PubMed)

Other Identifiers

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MCDC-SBMC

Identifier Type: -

Identifier Source: org_study_id

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