Time-to-Event Endpoint Methods in Antibiotic Trials

Document Type

Contribution to Book

Publication Date

4-23-2009

Publication Title

Design and Analysis of Clinical Trials with Time-to-Event Endpoints

ISBN

9781420066401

Abstract

Two efficacy endpoints of primary interest in the clinical development of antibiotic drugs for the treatment of infections are microbiological cure and clinical cure. Microbiological cure is typically defined as eradication of the infecting pathogen by the end of treatment and at the posttreatment follow-up visit. Similarly, clinical cure is defined as complete abatement of signs and symptoms of the infection by the end of treatment and at the posttreatment follow-up visit.

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