Fosfomycin Not Noninferior to Comparators for Bacteremic UTI
Fosfomycin not noninferior to ceftriaxone or meropenem for bacteremic urinary tract infection due to multidrug-resistant E. coli in adults
Urinary Tract Infection
Tebipenem HBr Gets Priority Review for Oral Treatment of Complicated UTI
The application includes data from the phase 3 ADAPT-PO trial, which evaluated the efficacy and safety of tebipenem HBr in 868 adults with cUTI or acute pyelonephritis.
Spero Therapeutics Seeks Approval of Oral Tebipenem HBr for Complicated UTI
The application submission is supported by data from the phase 3 ADAPT-PO trial, which compared oral tebipenem HBr to ertapenem in adults with cUTI or acute pyelonephritis.
Study Supports Shorter Antibiotic Course for Afebrile Men With UTI
The double-blinded, placebo-controlled noninferiority study included a total of 272 afebrile men from 2 US Veterans Affairs medical centers.
FDA Needs More Data on Sulopenem for Uncomplicated UTI
The NDA submission was supported by data from the phase 3 SURE1 clinical trial.
UTI Study Maps Escherichia coli Antimicrobial Resistance Trends in the United States
Investigators evaluated resistance to fluoroquinolones, nitrofurantoin, and trimethoprim-sulfamethoxazole in patients with uncomplicated urinary tract infection.
Trial Comparing Sulopenem to Ertapenem for cUTI Misses End Point
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])
Fetroja Approved for Complicated UTI in Patients With Limited or No Alternative Tx Options
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…
Recarbrio Approved To Treat Complicated UTI, Intra-Abdominal Infections
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,…
Facility Inspections, Manufacturing Deficiencies Hinder Approval of Contepo, According to FDA’s CRL
The FDA has issued a Complete Response Letter to Nabriva Therapeutics regarding the New Drug Application for Contepo (fosfomycin).
