Clinical trials

Objectives The main trial objective is to evaluate the efficacy of larvicide (LARV) or baited fly traps (TRAP), or both interventions combined, on filth fly density and hence transmission of diarrhoeal diseases. Primary Objective • To evaluate the efficacy of LARV or TRAP, or both interventions combined, in reducing the number of cases of all-cause diarrhoea (primary epidemiological endpoint). Secondary Objectives * To evaluate the efficacy of LARV or TRAP, or both interventions combined, in reducing filth fly density and species composition at the latrine level (primary entomological endpoint). * To evaluate the efficacy of LARV or TRAP, 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 LARV or TRAP, or both interventions combined, on enteric pathogen species composition and density (tertiary entomological endpoint). * To assess the impact of LARV or TRAP, 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 1-month wash-out period. The trial arms will be: 1. No intervention (control arm) 2. Dimilin® larvicide (intervention arm 1) 3. iCatchi® ProMax fly traps (intervention arm 2)