NCT01043796

Brief Summary

The purpose of this study is to determine whether insecticide treated wall liners, in combination with insecticide treated nets, reduce the incidence of malaria infections compared to insecticide treated nets alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,730

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2010

Longer than P75 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

January 6, 2010

Last Update Submit

February 2, 2015

Conditions

Malaria

Keywords

Insecticide treated wall linersInsecticide treated netsIncidence cohort

Outcome Measures

Primary Outcomes (1)

  • Incidence of new malaria infections

    Monthly

Study Arms (2)

Insecticide treated nets and wall liners

EXPERIMENTAL
Other: Insecticide treated nets and wall liners

Insecticide treated nets alone

ACTIVE COMPARATOR
Other: Insecticide treated nets alone

Interventions

Insecticide treated nets and wall linersOTHER

Participants will be provided a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme. Households where participants reside will be fitted with insecticide treated wall liners.

Insecticide treated nets and wall liners
Insecticide treated nets aloneOTHER

Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme

Insecticide treated nets alone

Eligibility Criteria

Age6 Months - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 months up to 11 years
  • Living in the study area and remaining in the study area for the duration of the study
  • Informed consent provided by parents

You may not qualify if:

  • No informed consent
  • Living outside the study area, or likely to move outside study area
  • Severely ill and unlikely to be able to complete study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Nyanza, Kenya

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • John E Gimnig, Ph.D.

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2014

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

KE(1)