A clinical trial outcome assessing the proportion of the study population achieving microbiological cure following treatment with an antibiotic.

Demonstration of microbiological cure (i.e., eradication of the putative pathogen from repeated culture of the site of infection) relies on availability of at least one post-baseline culture result. Where this is not available, for example, in complicated intra-abdominal infection; presumed microbiological eradication can be assessed based on resolution of clinical signs and symptoms.

Relapse is defined as, following demonstration of initial pathogen eradication, subsequent isolation of the pathogen from the original site of infection, with or without clinical deterioration. Superinfection is isolation of a pathogen not present at baseline.

See also Endpoints for antibacterial trials: timing of assessments.


Video definition by Dianna Taylor, GARDP (Switzerland).