NCT02394522

Brief Summary

The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of spatial repellent products in reducing the incidence of malaria infection in human cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between intervention and control arms.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 11, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

March 11, 2015

Last Update Submit

October 5, 2016

Conditions

Malaria

Keywords

MalariaSpatial RepellentsPlasmodium

Outcome Measures

Primary Outcomes (1)

  • Malaria Incidence

    Incidence of malaria infections among human cohorts during the follow-up period as detected by PCR

    104 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Spatial Repellent product without active ingredient (SHIELD)

Device: Spatial Repellent product without active ingredient (SHIELD)

Intervention

ACTIVE COMPARATOR

Spatial Repellent product with active ingredient (SHIELD)

Device: Spatial Repellent product with active ingredient (SHIELD)Device: Active Ingredient

Interventions

Spatial Repellent product with active ingredient (SHIELD)DEVICE

Spatial Repellent Product - Passive Emanator

Intervention
Active IngredientDEVICE

Transfluthrin (Active ingredient)

Also known as: Transfluthrin
Intervention
Spatial Repellent product without active ingredient (SHIELD)DEVICE

Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson

Also known as: Placebo SHIELD
Placebo

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-59 months
  • glucose-6-phosphate dehydrogenase (G6PD) normal (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden) and whose treatment with primaquine is implemented within national guidelines
  • Hb \> 5mg/dl
  • Sleeps in cluster \>90% of nights during any given month
  • No plans for extended travel (\<1month) outside of home during study
  • Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
  • Provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative

You may not qualify if:

  • children \< 6 months or \> 5 years
  • G6PD deficiency (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden and whose treatment with primaquine is implemented within national guidelines
  • Severe anemia
  • Sleeps in cluster \<90% of nights during any given month
  • Plans for extended travel (\>1month) outside of home during study
  • Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
  • No provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Macha Research Trust

Macha, Choma, Zambia

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Neil F Lobo, PhD

    University of Notre Dame, USA

    PRINCIPAL INVESTIGATOR

  • Nicole L Achee, PhD

    University of Notre Dame, USa

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 20, 2015

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

ZA(1)