NCT02294201

Spatial Repellent Products for the Control of Vector Borne Diseases - Malaria - Kenya

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Notre Dame · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DEVICE	Spatial Repellent product with active ingredient	Spatial Repellent product
DEVICE	Active ingredient	Transfluthrin (Active ingredient)
DEVICE	Spatial Repellent product without active ingredient (SHIELD)	Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-11-19
• Last updated: 2016-10-06

Locations

1 site across 1 country: Kenya