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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06179732
Other study ID # USDA01YEM - Nigeria
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 5, 2023
Est. completion date December 31, 2023

Study information

Verified date June 2023
Source The Mentor Initiative
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial. By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.


Recruitment information / eligibility

Status Completed
Enrollment 2400
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - Shelters with 1 or more children from 6-10 years old - Shelters with an adult/head of the household Exclusion Criteria: - Shelters without children from 6-10 years old

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Mesh - spatial repellent impregnated with transfluthrin (2500mg)
Mesh is one of the first spatial repellent tools to provide long-lasting protection to users, with predicted efficacy of 6-months. The active ingredient of Mesh is transfluthrin, a fast-acting volatile pyrethroid with low persistency, which can act either by killing or via sublethal toxicity that causes deviation (repellency) in host attraction, reducing host-contact and risk of infectious bites. The chemical passively releases into the air and interacts with vector odour receptors causing irritation. The design of Mesh is simple with a transfluthrin-infused sheet protected by plastic mesh and encased in a plastic frame. Mesh will be distributed to the intervention arm only.
Behavioral:
Information and Education Campaigns (IEC)
IEC campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home) using leaflets and word of mouth. IEC will be conducted in both arms.
Diagnostic Test:
test and treat malaria cases
All children in the cohort (both arms) will be tested by rapid diagnostic testing (RDT) monthly. If any children test positive, they will be treated with a course of 3-day artemisinin combination therapy (ACT) according to standard protocol and local guidelines. All children in the cohort will receive ACT to provide clearance of any malaria parasites during the baseline of the study.

Locations

Country Name City State
United Kingdom Sara Estecha Querol Haywards Heath West Sussex

Sponsors (5)

Lead Sponsor Collaborator
The Mentor Initiative Liverpool School of Tropical Medicine, SCJohnson, University of Maiduguri, US government

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary entomological outcome: vector density the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies 7 months
Primary epidemiological outcome: malaria incidence Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial. 7 months
Secondary feasibility, acceptance and uptake of Mesh To measure community and household acceptance and uptake of Mesh, a questionnaire will be conducted with the Mesh-receiving households. 7 months
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