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

ConditionDiarrheal Diseases

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age1+

SponsorThe Mentor Initiative

About this trial

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:

1. No intervention (control arm) 2. Inesfly® Carbapaint 10 insecticidal paint (intervention arm 1) 3. Dimilin® larvicide (intervention arm 2)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Long-lasting insecticidal paint - 1.0% (w/w) propoxur
Other intervention
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.
Insect growth regulator (IGR) - effervescent granule containing 2% diflubenzuron (20g/kg)
Other intervention
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.

Treatment groups

5,676 Participants

are divided into 3 treatment groups

Group A: ControlNo intervention 0 interventions

Group B: Insecticidal paint treatment of pit latrine wall inner surfaces in refugee campsExperimental treatment 1 intervention

Group C: Insecticide growth regulator treatment of faeces in pit latrines / open defecation sitesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame