Defining a target product profile for antimicrobials to treat severe paediatric bacterial enteric infections in low- and medium-income countries, caused by E. coli, Shigella, Salmonella and Campylobacter species.

Paediatric diarrhoea is associated with 500 000 childhood deaths each year in low- and middle-income countries (LMICs). Enteropathogenic Escherichia coli, Shigella spp., Salmonella spp. and Campylobacter spp. are among the most common causative bacterial pathogens, however, their burden and rates of antimicrobial resistance (AMR) are poorly quantified. Current treatment typically involves oral and intravenous rehydration fluids, nutritional support for malnourished children, antibiotics for severe bacterial infections, antiemetic and anti-diarrheal medications, and analgesics. The World Health Organization recommends first-line empirical treatment of ciprofloxacin, with alternatives of third-generation cephalosporins or azithromycin. At present, no new antibacterials are in development specifically to treat paediatric diarrhoea. Target product profiles (TPPs) are used typically in drug development and describe the desired characteristics of a new therapeutic. In this paper, we aim to define a TPP for the development of novel antimicrobials for the treatment of severe paediatric diarrhoea in LMICs. Oral and intravenous formulations are preferable. Safety, tolerability, resolution of clinical signs and symptoms must be equivalent or better than standard of care (SoC) therapy. Interactions with commonly used therapies such as zinc, milk and traditional cures should be minimal. In addition, formulations should be stable at elevated temperatures and for extended periods of time to facilitate access and distribution across LMICs.