Clinical trials of antibiotics typically incorporate extensive surveillance activities. These activities are designed to provide a picture of the pathogens in circulation at potential trial sites and their patterns of antibiotic resistance, for the indication being targeted in a trial.
This information is important for a range of reasons. It can inform selection of trial sites, by identifying the proportion of cases that would suitable for enrolment in a planned trial. It will also inform trial inclusion/exclusion criteria and the selection of appropriate comparator treatments.
Ideally, surveillance data are available for at least 2–3 years before a trial. Surveillance activities are also likely to be required post-approval to provide data on any changes to pathogen circulation over time.
Typically, resistance in circulating strains would be assessed by determination of minimum inhibitory concentrations (MICs) for at least 100 isolates collected within the past 3 years, for each organism associated with the clinical indication of interest.