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.
Urinary Tract Infection
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).
Avycaz Approved for Pediatric Use to Treat Complicated Intra-Abdominal, Urinary Tract Infections
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.
Antibiotic Delay Leads to Increased Risks in Seniors With UTI
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.
Plazomicin Noninferior to Meropenem for Complicated UTI
In second study, plazomicin may be beneficial for carbapenem-resistant Enterobacteriaceae infections
