Findings showed that the trial failed to demonstrate noninferiority, with a responder rate of 67.8% for sulopenem at the test of cure visit compared with 73.9% for ertapenem (difference of -6.1%; [95% CI, -12.0, -0.1])
The Food and Drug Administration (FDA) has approved Fetroja (cefiderocol; Shionogi) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. The treatment is indicated for patients aged ≥18 years with limited or no alternative…
The Food and Drug Administration (FDA) has approved Recarbrio (imipenem, cilastatin, relebactam; Merck) for the treatment of adult patients aged 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis, and for the treatment of complicated intra-abdominal infections (cIAI). Recarbrio is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor,…
The FDA has issued a Complete Response Letter to Nabriva Therapeutics regarding the New Drug Application for Contepo (fosfomycin).
The Food and Drug Administration has expanded the approval of Avycaz (ceftazidime and avibactam) to include pediatric patients aged ≥3 months for the treatment of complicated intra-abdominal infections, used in combination with metronidazole, and for complicated urinary tract infections.
Delaying or withholding antibiotics for older patients with a urinary tract infection (UTI) is associated with an increase in bloodstream infection and all-cause mortality.
In second study, plazomicin may be beneficial for carbapenem-resistant Enterobacteriaceae infections
Both filings have been granted Priority Review by the Agency.
For this study, the authors identified randomized controlled trials (RCTs) that compared SGLT2 inhibitors with placebo, no treatment, or another antidiabetic agent and reported on UTI outcome.
Zemdri carries a Boxed Warning describing reports of nephrotoxicity, ototoxicity, and neuromuscular blockade, as well as fetal harm if administered during pregnancy.
