Reducing Filth Fly Populations and Transmission of Diarrhoeal Pathogens in Harsh Settings

NCT07272122 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: UNLV-2025-203W911SR2510003
• Study Type: interventional
• Target: 5,676
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives The main trial objective is to evaluate the efficacy of insecticidal paint (PAINT) or larvicide (LARV), or both interventions combined, on filth fly density and hence transmission of diarrhoeal diseases. Primary Objective

• To evaluate the efficacy of PAINT or LARV, or both interventions combined, in reducing the number of cases of all-cause diarrhoea (primary epidemiological endpoint). Secondary Objectives
• To evaluate the efficacy of PAINT or LARV, or both interventions combined, in reducing filth fly density and species composition at the latrine level (primary entomological endpoint).
• To evaluate the efficacy of PAINT or LARV, or both interventions combined, in reducing filth fly density and species composition at the shelter level (secondary entomological endpoint). Tertiary Objectives
• To assess the impact of PAINT or LARV, or both interventions combined, on enteric pathogen species composition and density (tertiary entomological endpoint).
• To assess the impact of PAINT or LARV, or both interventions combined, on enteric pathogen antimicrobial resistance (AMR) prevalence (tertiary entomological endpoint). Trial Design The proposed trial will be a 3-period, 3-group, interventional non-randomized cross-over trial with parallel control (Table 1). The unit of intervention will be an individual refugee camp. Each implementation phase will be 6 months, followed by a 2-month wash-out period. The trial arms will be:
• No intervention (control arm)
• Inesfly® Carbapaint 10 insecticidal paint (intervention arm 1)
• Dimilin® larvicide (intervention arm 2)

Conditions

Diarrheal Diseases

Keywords

Filth flies; Vector control; Conflict displaced people; Temporary shelter; Cross-over trial

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of insecticidal paint (PAINT) or insect growth regulator (LARV), or both interventions combined, in reducing the number of cases of all-cause diarrhoea (primary epidemiological endpoint).

  The primary outcome will be all-cause diarrhoeal case incidence in children \<5 and individuals \>15. A diarrhoeal case is defined by WHO as the passage of 3 or more loose or liquid stools per day (or more frequent passage than is normal for the individual). Epidemiological data will be collected from 2 sources during baseline and each of 3 implementation phases. We will collect information on 1) diarrhoea incidence from local health facilities; and 2) shelter level diarrhoea incidence using bi-weekly surveys. Passive surveillance data on diarrhoeal cases from camp residents will be obtained from the nearby health facilities. Permission will be sought from these facilities during trial baseline, and bi-weekly data will be collected during each 6-month implementation phase.

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

Secondary Outcomes (4)

• Filth fly density and species composition

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

• Filth fly species composition - latrine level

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

• Filth fly species density - shelter level

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

• Filth fly species composition - shelter level

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

Other Outcomes (3)

• Impact of PAINT or LARV, or both interventions combined, on enteric pathogen density

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

• Impact of PAINT or LARV, or both interventions combined, on enteric pathogen species composition

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

• Impact of PAINT or LARV, or both interventions combined, on enteric pathogen antimicrobial prevalence

  At trial baseline and then every fortnight during each of three 6-month intervention phases.

Study Arms (3)

Control

NO INTERVENTION

Insecticidal paint treatment of pit latrine wall inner surfaces in refugee camps

EXPERIMENTAL

Inesfly® Carbapaint 10 (Inesfly Corporation, Valencia, Spain) is a water-based polymer coating containing a microencapsulated suspension of 1.0% (w/w) propoxur (carbamate), for slow release to prolong efficacy. Propoxur is a non-repellent active ingredient (AI) and when used on pit latrine walls, flies will land on the surface and receive a lethal insecticidal dose. All eligible pit latrines assigned to this intervention arm will be treated with Inesfly® Carbapaint 10 at the beginning of each 6-month implementation phase; pit latrines with at least 3 standing walls, will be eligible.

Other: Long-lasting insecticidal paint - 1.0% (w/w) propoxur

Insecticide growth regulator treatment of faeces in pit latrines / open defecation sites

EXPERIMENTAL

All eligible pit latrines (with at least 3 standing walls) assigned to this intervention arm will be treated with Dimilin® GR-2 at 0.5 kg/10m2; granules will be sprinkled onto damp sewage per pit latrine. If waste is desiccated, this intervention will be diluted in water and applied as a spray. This intervention will be re-applied to pit latrines and open defecation sites, every month during each 6-month implementation phase.

Other: Insect growth regulator (IGR) - effervescent granule containing 2% diflubenzuron (20g/kg)

Interventions

Long-lasting insecticidal paint - 1.0% (w/w) propoxur OTHER

Inesfly® Carbapaint 10 (Inesfly Corporation, Valencia, Spain) is a water-based polymer coating containing a microencapsulated suspension of 1.0% (w/w) propoxur (carbamate), for slow release to prolong efficacy. Propoxur is a non-repellent active ingredient (AI) and when used on pit latrine walls, flies will land on the surface and receive a lethal insecticidal dose. All eligible pit latrines assigned to this intervention arm will be treated with Inesfly® Carbapaint 10 at the beginning of each 6-month implementation phase; pit latrines with at least 3 standing walls, will be eligible.

Also known as: Inesfly carbapaint 10

Insecticidal paint treatment of pit latrine wall inner surfaces in refugee camps

Insect growth regulator (IGR) - effervescent granule containing 2% diflubenzuron (20g/kg) OTHER

This intervention will interrupt filth fly development at the larval / pupal stage, to reduce overall population density. All eligible pit latrines (with at least 3 standing walls) assigned to this intervention arm will be treated with Dimilin® GR-2 at 0.5 kg/10m2; granules will be sprinkled onto damp sewage per pit latrine. If waste is desiccated, this intervention will be diluted in water and applied as a spray. This intervention will be re-applied to pit latrines and open defecation sites, every month during each 6-month implementation phase.

Also known as: Dimilin® GR-2

Insecticide growth regulator treatment of faeces in pit latrines / open defecation sites

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals of either \<5 years old or \>15 years old all ages
• Slept in camp ≥27 nights during any given month
• Individual is not severely malnourished, sick, anemic (self-reported), has signs of clinical decompensation, and/or has any other chronic co-morbidities (e.g. HIV or cancer)
• No plans for extended travel (\>1 month) outside of camp during study
• Resides in an easily accessible dwelling and is present at time of enrolment
• Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
• Provision of informed consent form signed by the parent(s) or guardian (under 5s), able to give informed consent as an adult or able to give informed assent for children \>15 years

You may not qualify if:

• Child \< 1 years old (due to breastfeeding) or aged \>5 and \< 15 years old
• Slept in camp \<27 nights during any given month
• Individual is severely malnourished, sick, anemic, has signs of clinical decompensation, and/or has any other chronic co-morbidities (e.g. HIV or cancer)
• Plans for extended travel (\>1 month) outside of camp during study
• Not present at time of enrolment
• Participating or planning to participate in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
• No provision of informed consent form signed by the parent(s) or guardian (under 5s), unable to give informed consent as an adult or unable to give informed assent for children \>15 years

Sponsors & Collaborators

• The Mentor Initiative: lead
• University of Nevada, Las Vegas: collaborator

Study Sites (1)

The MENTOR Initiative, Bunj Town, Maban

Bunj, Maban County, South Sudan

Location

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MeSH Terms

Interventions

Propoxur; Juvenile Hormones; Diflubenzuron

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Insect Hormones; Invertebrate Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Richard J Allan, PhD

  The Mentor Initiative

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard James Allan, PhD

CONTACT

+44 796193670; richard.allan@mentor-initiative.org

Louisa Messenger, PhD

CONTACT

+1 702-449-3295; louisa.messenger@unlv.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: DSMB committee Trial Steering Committee NB: these committees can request unblinding of data if they have serious concerns regarding adverse event monitoring.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3-period, 3-group, interventional non-randomised cross-over trial with parallel control

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 9, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 19, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be available upon publication of the main trial manuscript, following trial completion and will be available indefinitely.
• Access Criteria: Summary findings from trial IPD will be published in open-access, peer reviewed papers and their supporting information. Following trial completion, IPD will be available indefinitely, upon publication of the main trial manuscript. All other relevant de-identified IPD are available from the trial Principal Investigators upon reasonable request.

Locations

SO (1)