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Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania

NCT ID: NCT05150808

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

12500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-12-31

Brief Summary

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Malaria is a major public health problem in Africa. An important way to control the disease is by Indoor Residual Spraying of insecticide in houses. Insecticide resistance has become a major problem. This trial will evaluate a novel insecticide against those insecticide resistant mosquito vectors in Tanzania E Africa.

Detailed Description

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Background: Indoor residual spraying (IRS) is one of the major methods of malaria vector control across sub-Saharan Africa, responsible for reducing malaria incidence by 10% since 2000. However, effective vector control is increasingly threatened by the rapid spread of insecticide resistance. Consequently, there have been investments in the development of new insecticides for IRS that possess novel modes of action with long residual activity, low mammalian and environmental toxicity and minimal cross-resistance. VECTRONTM T500, a new IRS insecticide containing the active ingredient broflanilide 50% WP, has been shown to be efficacious against both pyrethroid-susceptible and -resistant vector strains on mud and concrete substrates in phase II experimental hut trials in Tanzania.

Method: A two-arm non-inferiority cluster randomized controlled trial will be conducted in Muheza District, Tanga Region, Tanzania. VECTRONTM T500 will be compared to the IRS formulation Fludora® Fusion (active ingredients: clothianidin 50% WP + deltamethrin 6.25% WP). The predominant malaria vectors in the study area are pyrethroid-resistant Anopheles gambiae s.s., An. arabiensis and An. funestus s.s. Sixteen selected clusters of 75-200 households in each cluster will be pair-matched on baseline vector densities and allocated to reference and intervention arms. Consenting households in the intervention arm will be sprayed with VECTRONTM T500 and those in the reference arm will receive Fludora® Fusion. Monthly CDC light traps will collect mosquitoes to determine vector density, indoor biting, sporozoite and entomological inoculation rates (EIR). Phenotypic resistance to IRS active ingredients will be assessed using CDC bottle bioassays. Molecular and metabolic resistance mechanisms will be characterised among Anopheles field populations from both trial arms. Residual efficacy of both brands of insecticide will be monitored for 12 months post-spraying. A semi-structured questionnaire and focus group discussions will explore social and cultural factors that influence acceptability, perceived adverse effects and benefits of IRS.

Discussion: This protocol describes a phase III non-inferiority evaluation of a novel IRS product to reduce the density and EIR of pyrethroid-resistant Anopheles vectors. If VECTRONTM T500 proves non-inferior to Fludora® Fusion, it may be considered as an additional vector control product for malaria prevention and insecticide resistance management schemes.

Conditions

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Malaria,Falciparum

Keywords

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vector control insecticide indoor residual spraying of mosquitoes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster Randomised Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention IRS

Intervention IRS insecticide will be sprayed on the walls and ceilings of 8 clusters

Group Type ACTIVE_COMPARATOR

IRS insecticide: Vectron T500

Intervention Type OTHER

public health insecticide

Control IRS

WHO approved IRS insecticide will be sprayed on the walls and ceilings of 8 clusters

Group Type ACTIVE_COMPARATOR

IRS insecticide: Vectron T500

Intervention Type OTHER

public health insecticide

Interventions

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IRS insecticide: Vectron T500

public health insecticide

Intervention Type OTHER

Other Intervention Names

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broflanilide

Eligibility Criteria

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Inclusion Criteria

All households who consent to IRS malaria control

Exclusion Criteria

none
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

Kilimanjaro Christian Medical Centre, Tanzania

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Institute of Medical Research

Muheza, , Tanzania

Site Status RECRUITING

London School of Hygiene & Tropical Medicine

London, , United Kingdom

Site Status RECRUITING

Countries

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Tanzania United Kingdom

Facility Contacts

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Patrick Tungu, Dr

Role: primary

Mark W Rowland, PhD

Role: primary

Terri O O'Halloran, BA

Role: backup

References

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Mbewe NJ, Tungu PK, Messenger LA, Bradley J, Mangesho PE, Shirima B, Moshi O, Shayo MF, Seif M, Portwood NM, Snetselaar J, Azizi S, Magogo F, Mabenga P, Sudi W, Mlay G, Kirby MJ, Mosha FW, Kisinza W, Matowo J, Small G, Rowland MW. A noninferiority cluster randomised evaluation of a broflanilide indoor residual spraying insecticide, VECTRON T500, for malaria vector control in Tanzania. Sci Rep. 2025 Apr 29;15(1):15013. doi: 10.1038/s41598-025-99809-9.

Reference Type DERIVED
PMID: 40301570 (View on PubMed)

Tungu PK, Rowland MW, Messenger LA, Small GJ, Bradley J, Snetselaar J, Kirby MJ, Mbewe NJ. Large-scale (Phase III) evaluation of broflanilide 50WP (VECTRON T500) for indoor residual spraying for malaria vector control in Northeast Tanzania: study protocol for a two-arm, non-inferiority, cluster-randomised community trial. BMC Infect Dis. 2022 Feb 21;22(1):171. doi: 10.1186/s12879-022-07138-3.

Reference Type DERIVED
PMID: 35189830 (View on PubMed)

Other Identifiers

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ITDCZI93

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Ph3 Vectron Tz

Identifier Type: -

Identifier Source: org_study_id