Spatial Repellents for Vector Control (AEGIS Mali)

April 1, 2024 updated by: University of Notre Dame

Spatial Repellent Products for Control of Vector Borne Diseases

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1911

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

  • Mali
      • Bamako, Mali
        • Catholic Relief Services
      • Bamako, Mali
        • Malaria Research and Training Center (MRTC), University of Bamako, Mali

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 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of first-time malaria infections during intervention period.
Time Frame: 24 months
Measured by microscopy in children aged between 6 months to 10 years.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of overall new malaria infections during intervention period.
Time Frame: 24 months
Measured by microscopy in children aged between 6 months to 10 years.
24 months
Parasite-species-specific first-time malaria infections.
Time Frame: 24 months
Measured by microscopy in children aged between 6 months to 10 years.
24 months
Parasite-species-specific overall malaria infections.
Time Frame: 24 months
Measured by microscopy in children aged between 6 months to 10 years.
24 months
Number of first-time malaria infections by two age groups (≤ 59 months old; 5 years old to 10 years old).
Time Frame: 24 months
Measured by microscopy in children aged between 6 months to 10 years.
24 months
Number of overall malaria infections by two age groups (≤ 59 months old; 5 years to 10 years old).
Time Frame: 24 months
Measured by microscopy in children aged between 6 months to 10 years.
24 months
Anopheline-human contact (indoor and outdoor) using human biting rate (HBR) as an indicator for all anophelines and by anopheline species.
Time Frame: 24 months
Measured by human-landing catch (HLC) during 12-h intervals on a quarterly basis during intervention period.
24 months
Anopheline parity rate as an indicator of population age structure for all anophelines and by anopheline species.
Time Frame: 24 months
Measured by mosquito ovarian dissections from a sub-sample of anophelines collected during HLC procedures during intervention period.
24 months
Anopheline infectivity using sporozoite rate as an indicator for all anophelines and by anopheline species.
Time Frame: 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.
24 months
Anopheline infectivity using entomological inoculation rate (EIR) as an indicator for all anophelines and by anopheline species.
Time Frame: 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.
24 months
CDC-light trap indoor density for all anophelines and by anopheline species.
Time Frame: 24 months
Measured by CDC-light trap collections during 12-h intervals on a monthly basis during intervention period.
24 months
Insecticide resistance.
Time Frame: 30 months
Measured by WHO filter paper test and CDC bottle assays during baseline and intervention period.
30 months
Adverse Events and Serious Adverse Events.
Time Frame: 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.
30 months

Collaborators and Investigators

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

Sponsor

University of Notre Dame

Collaborators

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

Investigators

  • Principal Investigator: Suzanne Van Hulle, M.H.S, Catholic Relief Services
  • Study Director: John P Grieco, Ph.D., University of Notre Dame

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

July 8, 2021

Primary Completion (Actual)

March 2, 2024

Study Completion (Actual)

March 2, 2024

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-10-6245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Analytical datasets will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.

IPD Sharing Time Frame

The data and supporting information will be made available 12 months following completion of data analysis and will remain open access in the public domain.

IPD Sharing Access Criteria

Open-access repository distributed under the terms of the Creative Commons Attribution (CC-BY) License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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