Not Yet RecruitingPhase 3

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

South Sudan5,676 participantsStarted 2025-12-10

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

Who can participate

Age range1 Year

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:- * 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 Exclusion Criteria: * 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 inf…

What they're measuring

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).

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

Trial details

NCT IDNCT07272122

SponsorThe Mentor Initiative

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-31

Contact for this trial

Richard James Allan, PhD

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

View on ClinicalTrials.gov More Diarrheal Diseases trials