Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania
Primary Purpose
Malaria,Falciparum
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IRS insecticide: Vectron T500
Sponsored by
About this trial
This is an interventional prevention trial for Malaria,Falciparum focused on measuring vector control, insecticide, indoor residual spraying of mosquitoes
Eligibility Criteria
Inclusion Criteria:
All households who consent to IRS malaria control
Exclusion Criteria:
none
Sites / Locations
- National Institute of Medical ResearchRecruiting
- London School of Hygiene & Tropical MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention IRS
Control IRS
Arm Description
Intervention IRS insecticide will be sprayed on the walls and ceilings of 8 clusters
WHO approved IRS insecticide will be sprayed on the walls and ceilings of 8 clusters
Outcomes
Primary Outcome Measures
Vector density
Reduction in vector population density
Sporozoite rate
Reduction in sporozoite rate
Entomological inoculation rate EIR
Reduction in EIR
Secondary Outcome Measures
Full Information
NCT ID
NCT05150808
First Posted
November 26, 2021
Last Updated
November 26, 2021
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
1. Study Identification
Unique Protocol Identification Number
NCT05150808
Brief Title
Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania
Official Title
WHO Phase III Evaluation of Vectron T500 (Broflanilide 50WP) for IRS in Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria,Falciparum
Keywords
vector control, insecticide, indoor residual spraying of mosquitoes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomised Trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
12500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention IRS
Arm Type
Active Comparator
Arm Description
Intervention IRS insecticide will be sprayed on the walls and ceilings of 8 clusters
Arm Title
Control IRS
Arm Type
Active Comparator
Arm Description
WHO approved IRS insecticide will be sprayed on the walls and ceilings of 8 clusters
Intervention Type
Other
Intervention Name(s)
IRS insecticide: Vectron T500
Other Intervention Name(s)
broflanilide
Intervention Description
public health insecticide
Primary Outcome Measure Information:
Title
Vector density
Description
Reduction in vector population density
Time Frame
12-15 months
Title
Sporozoite rate
Description
Reduction in sporozoite rate
Time Frame
12-15 months
Title
Entomological inoculation rate EIR
Description
Reduction in EIR
Time Frame
12-15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All households who consent to IRS malaria control
Exclusion Criteria:
none
Facility Information:
Facility Name
National Institute of Medical Research
City
Muheza
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Tungu, Dr
Phone
+255715487232
Email
patrickkjiatungu@hotmail.com
Facility Name
London School of Hygiene & Tropical Medicine
City
London
ZIP/Postal Code
WC1E 7HT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark W Rowland, PhD
Phone
+44 7595090405
Ext
4719
Email
mark.rowland@lshtm.ac.uk
First Name & Middle Initial & Last Name & Degree
Terri O O'Halloran, BA
Phone
+44 7762477027
Ext
4718
Email
Terri.O'Halloran@lshtm.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35189830
Citation
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.
Results Reference
derived
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Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania
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