AEGIS Mali: Spatial Repellents for Vector Control

Sponsor

University of Notre Dame (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04795648

Collaborator

SC Johnson, A Family Company (Other), fhiClinical (Other), Malaria Research and Training Center, Bamako, Mali (Other), Catholic Relief Services (Other)

1,920

Enrollment

Locations

Arms

28.8

Anticipated Duration (Months)

960

Patients Per Site

33.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to demonstrate and quantify the protective efficacy of a single Spatial Repellent (SR) product, in reducing malaria infection in a human cohort. The study design will be a prospective cluster Randomized Control Trial (cRCT).

Condition or Disease	Intervention/Treatment	Phase
Malaria	Device: Transfluthrin Device: Placebo	N/A

Detailed Description

Children ≥ 6 months to < 10 years of age will be enrolled in a single cohort across 60 clusters (30 clusters per treatment arm). The cohort will be followed for 6 months for baseline covariate measurements and 24 months with intervention. Blood samples will be taken once every 4 weeks from all cohort subjects to test for malaria infection and whenever a subject reports a recent history of fever (within previous 48 hours). During follow up of enrolled subjects, study clinicians will have the option to conduct a Hb test for enrolled subjects when they may present signs of anemia to see if they might need additional treatment beyond malaria ACTs (if malaria infection is indicated). Rapid Diagnostic Tests (RDTs) will be used for point-of-care diagnosis of malaria infection with microscopy used to confirm infection status. All positive malaria infections as indicated by either RDT or microscopy, clinical and asymptomatic, will be treated. If a subject has a RDT negative outcome but a positive microscopy diagnosis, follow up treatment for the malaria infection will be provided to the subject within 72hrs of the microscopy read. Cohort subjects who test positive for malaria by either RDT or microscopy, symptomatic or asymptomatic, during both scheduled and unscheduled visits will be treated with ACTs. The incidence of malaria infection will be measured by microscopy and estimated and compared between treatment arms to determine the benefit of using an SR in an area with high, seasonal transmission of malaria.

Entomological endpoints of exposure risk to mosquitoes will also be measured to identify entomological correlates of SR efficacy that may be useful for the evaluation of new SR products. Twenty clusters (10 SR, 10 placebo) will be randomly selected to estimate the impact of the SR on entomological measures of malaria transmission. Within each cluster, light trap collections will be conducted monthly in 10 randomly selected households to assess the impact of SRs on the density of Anopheles mosquitoes indoors. Human landing catches will be done indoors and outdoors in 6 intervention and 6 control clusters (the 12 clusters will remain fixed throughout the study) in four houses (randomly selected) in each cluster for the period of 2 nights (total of 48 houses across both arms) once every quarter (3 months) to determine the effect of SR on the host seeking behavior of mosquitoes.

The SR will be a new formulation of transfluthrin. This active ingredient (AI) is widely used in mosquito coils and other household pest control products. The new formulation is a passive emanator that will release the AI over a period of up to four weeks. The emanator will consist of a pre-treated piece of cellulose acetate, which will be positioned within consenting households according to manufacturer specifications. The SRs and placebos for this study will be designed and manufactured by S.C. Johnson, Inc. USA.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1920 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study design will be a prospective cluster Randomized Control Trial (cRCT)The study design will be a prospective cluster Randomized Control Trial (cRCT)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Spatial Repellent Products for Control of Vector Borne Diseases

Actual Study Start Date :

Jul 8, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spatial Repellent Transfluthrin	Device: Transfluthrin Passive emanator with formulated transfluthrin
Placebo Comparator: Placebo Inert ingredients	Device: Placebo Passive emanator with formulated inert ingredients

Arm

Intervention/Treatment

Experimental: Spatial Repellent

Transfluthrin

Device: Transfluthrin

Passive emanator with formulated transfluthrin

Placebo Comparator: Placebo

Inert ingredients

Device: Placebo

Passive emanator with formulated inert ingredients

Outcome Measures

Primary Outcome Measures

Number of first-time malaria infections during intervention period. [24 months]
Measured by microscopy in children aged between 6 months to 10 years.

Secondary Outcome Measures

Number of overall new malaria infections during intervention period. [24 months]
Measured by microscopy in children aged between 6 months to 10 years.
Parasite-species-specific first-time malaria infections. [24 months]
Measured by microscopy in children aged between 6 months to 10 years.
Parasite-species-specific overall malaria infections. [24 months]
Measured by microscopy in children aged between 6 months to 10 years.
Number of first-time malaria infections by two age groups (≤ 59 months old; 5 years old to 10 years old). [24 months]
Measured by microscopy in children aged between 6 months to 10 years.
Number of overall malaria infections by two age groups (≤ 59 months old; 5 years to 10 years old). [24 months]
Measured by microscopy in children aged between 6 months to 10 years.
Anopheline-human contact (indoor and outdoor) using human biting rate (HBR) as an indicator for all anophelines and by anopheline species. [24 months]
Measured by human-landing catch (HLC) during 12-h intervals on a quarterly basis during intervention period.
Anopheline parity rate as an indicator of population age structure for all anophelines and by anopheline species. [24 months]
Measured by mosquito ovarian dissections from a sub-sample of anophelines collected during HLC procedures during intervention period.
Anopheline infectivity using sporozoite rate as an indicator for all anophelines and by anopheline species. [24 months]
Measured by laboratory detection of sporozoites in mosquito head-preps from a sub-sample of anophelines collected during HLC and/or CDC-light trap procedures during intervention period.
Anopheline infectivity using entomological inoculation rate (EIR) as an indicator for all anophelines and by anopheline species. [24 months]
Measured by calculating the number of sporozoite-infected anopheline mosquitoes captured per person during intervention period from HLC and/or CDC-light trap procedures.
CDC-light trap indoor density for all anophelines and by anopheline species. [24 months]
Measured by CDC-light trap collections during 12-h intervals on a monthly basis during intervention period.
Insecticide resistance. [30 months]
Measured by WHO filter paper test and CDC bottle assays during baseline and intervention period.
Adverse Events and Serious Adverse Events. [30 months]
Measured by solicited and unsolicited reports during baseline and intervention period. Mean, minimum and maximum frequency and percentage of Adverse Events(AEs) and Severe Adverse Events (SAEs) across clusters among enrolled subjects will be summarized by treatment arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children ≥ 6 months to < 10 years of age
Children with Hb > 7 g/dL and no signs of known chronic disease or other other serious illness
Sleeps in cluster ≥ 90% of nights during any given month
Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
Provision of informed consent (and/or assent) form (ICF) signed by the parent(s) or guardian

Exclusion Criteria:

Children < 6 months or ≥ 10 years
Childrend with Hb <= 7 g/dL with signs of known chronic disease or other serious illness, or Hb <6 g/dL with signs of clinical decompensation
Sleeps in cluster <90% of nights during any given month
Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
No provision of ICF (and/or assent) signed by the parent(s) or guardian