Viewpoints

Running a phase 3 trial for a new drug for gonorrhoea during the coronavirus pandemic – by Markus Heep, Esther Bettiol, Tanyaporn Wansom and Hilary Johnstone

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Zoliflodacin is an oral antibiotic with a novel mode of action distinct from quinolones. The majority of uncomplicated urogenital and rectal gonococcal infections were successfully treated with oral zoliflodacin in a phase 2 study conducted in the U.S. Zoliflodacin offers many of the WHO preferred characteristics for gonorrhoea therapy, including single dose therapy, low rate of side effects, and both urogenital and extragenital site efficacy.

A lesson learned from COVID-19: The importance of non-inferiority (NI) trials for developing new antimicrobial agents before widespread need – by John Rex

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In this Antimicrobial Viewpoint article, I explore the two types of clinical trials: Superiority and non-inferiority (NI) as well as the lethal danger of Infections and how antibiotics are best developed before we need them. I also explain how non-inferiority trials are for the public good and allow us to avoid COVID-19-like situations and explain why superiority efficacy is (hopefully) unattainable, but superior utility is possible.

Why we need a new access model for antibiotics – by Yann Ferrisse and Fernando Pascual Martinez

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Whether it concerns an old or new antibiotic, access to these drugs represents a major challenge globally and this is not a recent problem. The COVID-19 pandemic has exacerbated the shortages of existing antibiotics and the lack of new and innovative treatments. It has led to the recognition that we not only need efficient treatments to be available for patients when and where needed but also that we need to have innovative treatments ready prior to reaching an emergency situation.