Tag Archives: bacteriological response

Microbiological Response as Primary Efficacy Endpoint for Antibacterials

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We have often mentioned the central importance of microbiological response as an endpoint in trials of antibacterials. This is contrary to other therapeutic areas, in which the etiology is less understood and where surrogate markers are needed. In bacterial infectious diseases we have the luxury of knowing exactly what causes Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials→

The Weak Correlation Between Antibiotic Action and Mortality

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At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the most important clinical endpoint[2]. FDA felt so strongly about this, Continue reading The Weak Correlation Between Antibiotic Action and Mortality→