NCT01231880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
740

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

1.6 years

First QC Date

October 29, 2010

Last Update Submit

May 22, 2013

Conditions

Malaria

Keywords

Malaria

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 year

  • Cognitive function tests

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

    1 year

Secondary Outcomes (5)

  • Risk of parasitemia

    1 year

  • Risk of hospital admissions

    1 year

  • Risk of adverse events

    1 year

  • School performance

    1 year

  • Prevalence of anemia

    1 year

Study Arms (3)

Four monthly IPT

EXPERIMENTAL

IPT give once a school term (every four months)

Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)

Monthly IPT

EXPERIMENTAL

IPT given every month

Drug: Monthly IPT using DP

Placebo

PLACEBO COMPARATOR

No active drug in the placebo

Drug: Placebo given every month

Interventions

Four monthly IPT with dihydroartemisinin Piperaquine (DP)DRUG

Given every 4 months (once a school term)

Also known as: Duocortexin
Four monthly IPT
Monthly IPT using DPDRUG

Given every month

Also known as: Duocortexin
Monthly IPT
Placebo given every monthDRUG

No active ingredient

Also known as: Placebo
Placebo

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulanda Sub-district

Tororo, Uganda, 256, Uganda

Location

Related Publications (2)

  • 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.

    PMID: 27401569DERIVED

  • 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.

    PMID: 24621953DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Joaniter I Nankabirwa, MSc CEB

    Makerere University Kampala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 1, 2010

Study Start

February 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

UG(1)