Spatial Repellent Products for the Control of Vector Borne Diseases - Malaria - Tanzania (SR-M-Tz)

October 5, 2016 updated by: University of Notre Dame
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The primary epidemiological endpoint will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by polymerase chain reaction assay (PCR). This measure will inform PE (the reduction of incidence) between intervention and control study arms using the formula: PE =[(Ip - Ia)/Ip]* 100%; based on an expected minimum effect size of 30%. First time infections in these subjects will offer relatively unambiguous evidence of the extent of exposure to infectious mosquito bites. The primary entomological endpoint will be adult densities of vector species via human-landing catch (HLC) from sentinel households from intervention and control arms over the follow-up period.

Secondary epidemiological endpoints will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by microscopy and the total number of cases averted (i.e., all Plasmodium spp. infections in cohort subjects). Secondary entomological endpoints include number of sporozoite infected mosquitoes, parity and species-specific effects of the spatial repellent product.

Both epidemiological and entomological endpoints will be utilized to look at the relationship between SR and PE based on product coverage (to include diversion and community effects) and insect behavior. The prospect of SR associated temporal cumulative effects on study endpoints (epidemiological and entomological) over transmission seasons will also be investigated by using the cumulative incidence of infection over the season and applying a survival curve analysis of the cohort data.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Bagamoyo, Tanzania
        • Ifakara Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Temperature ≤38.0°C) and no moderate or severe acute illness/infection on the day of inclusion
  • 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

Exclusion Criteria:

  • 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
  • Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Repellent product with no active ingredient
Device: Spatial Repellent product without active ingredient (SHIELD)
Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
Other Names:
  • Placebo SHIELD
Active Comparator: Intervention
Spatial Repellent product with active ingredient
Device: Spatial Repellent product with active ingredient
Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
Other Names:
  • SHIELD
Device: Active ingredient
Transfluthrin (Active ingredient)
Other Names:
  • Transfluthrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malaria Incidence
Time Frame: 104 weeks
Incidence of malaria infections among human cohorts during the follow-up period as detected by PCR
104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Notre Dame

Collaborators

Ifakara Health Institute

Investigators

  • Principal Investigator: Neil Lobo, PhD, University of Notre Dame
  • Principal Investigator: Nicole Achee, PhD, University of Notre Dame

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR-M-TZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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