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

Malaria,Falciparum Clinical Trial

Official title:

WHO Phase III Evaluation of Vectron T500 (Broflanilide 50WP) for IRS in Tanzania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150808
• Other study ID #: Ph3 Vectron Tz
• Secondary ID: ITDCZI93
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12500
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

All households who consent to IRS malaria control

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Malaria, Falciparum
• Malaria,Falciparum

Intervention

Other:
• IRS insecticide: Vectron T500
public health insecticide

Locations

Country	Name	City	State
Tanzania	National Institute of Medical Research	Muheza
United Kingdom	London School of Hygiene & Tropical Medicine	London

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Kilimanjaro Christian Medical Centre, Tanzania, National Institute for Medical Research, Tanzania

Countries where clinical trial is conducted

Tanzania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vector density	Reduction in vector population density	12-15 months
Primary	Sporozoite rate	Reduction in sporozoite rate	12-15 months
Primary	Entomological inoculation rate EIR	Reduction in EIR	12-15 months