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An analysis of urine specimens from male patients in Germany found high levels of antibiotic resistance in the most frequent causes of urinary tract infections (UTIs), researchers reported today in Eurosurveillance.

The retrospective observational study analyzed routinely collected urine specimens from 102,736 adult men treated at outpatient practices across Germany from 2015 through 2020. Researchers focused on the distribution of bacteria and the resistance of the three most common bacteria to frequently used oral antibiotics for UTIs. A secondary aim was to identify risk factors for the occurrence UTIs caused by antibiotic-resistant Escherichia coli.

The three most frequent bacteria were E coli (38.4%), Enterococcus faecalis (16.5%), and Proteus mirabilis (9.3%). While E coli resistance to first-line, recommended antibiotics for uncomplicated UTIs (fosfomycin and nitrofurantoin) was low, resistance to amoxicillin (45.7%), TMP (26.6%), and ciprofloxacin (19.8%) was common, and multidrug resistance was high (22.9%). Resistance of E faecalis to ciproflxacin was also high (29.3%), as was P mirabilis resistance to TMP (41.3%) and ciprofloxacin (16.6%). Resistance to TMP and ciprofloxacin was significantly higher among bacteria derived from recurrent UTIs.

Multivariable logistic regression identified age (90 years or older) and recurrent UTI as independent risk factors for E coli UTIs with resistance to TMP and ciprofloxacin.

The study authors say the findings suggest urine culture should always be performed before therapy in men with suspected UTIs, and that the use of TMP and ciprofloxacin should be limited. Jul 28 Eurosurveill study

San Diego-based biotechnology company Cidara Therapeutics announced yesterday that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its novel antifungal candidate rezafungin.

The company submitted the NDA for rezafungin—an echinocandin antifungal—for the treatment of candidemia and invasive candidiasis based on positive results from the phase 3 ReSTORE and phase 2 STRIVE trial. In both trials, a once-weekly dose of rezafungin demonstrated statistical non-inferiority to once-daily caspafungin, meeting the primary endpoints for the FDA and the European Medicines Agency.

The FDA has granted rezafungin Qualified Infectious Disease Product designation, which confers priority review of the NDA.  If the NDA is accepted, Cidara expects an FDA decision on approval of the drug could come in early 2023. No new therapies for candidemia and invasive candidiasis, which are caused by a yeast called Candida and are associated with high rates of morbidity and mortality, have been approved by the FDA in over a decade.

“If approved, rezafungin would represent an important new treatment option for patients at risk of these potentially deadly diseases," Cidara President and CEO Jeffrey Stein, PhD, said in a company press release.

Cidara also announced that it has entered into a license agreement with Melinta Therapeutics, of Morristown, New Jersey, under which Melinta will acquire an exclusive license to commercialize rezafungin in the United States. Jul 27 Cidara Therapeutics press release

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