Definition:

Antibacterial treatment outcomes are measured at pre-specified intervals from the start of treatment at (1) the end of treatment and (2) time points thereafter to demonstrate maintenance of clinical/microbiological cure.

Assessment of clinical (and where appropriate, microbiological) cure will typically occur at the end of treatment; either when the subject is assessed as having achieved clinical cure and no further treatment is necessary; at the time of switch from intravenous to oral therapy; or when they have reached the pre-defined maximum duration of treatment in the absence of clinical cure. Thereafter, assessment of maintenance of clinical cure is performed at a pre-specified timepoint(s), e.g., 14–28 days after start of treatment, depending on the indication/site of infection.

See also Endpoints for antibacterial trials: microbiologic.

 

Video definition by Dianna Taylor, GARDP (Switzerland).

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