Updated Guidelines on Optimal Antibiotic Dosing for Patients With Obesity
Researchers evaluated clinical trial data and drug databases to provide updated recommendations on antimicrobial dosing for patients with obesity.
Researchers evaluated clinical trial data and drug databases to provide updated recommendations on antimicrobial dosing for patients with obesity.
Researchers assessed whether adverse outcomes in women with uncomplicated UTI are more likely when initial antibiotic therapy does not cover the causative uropathogen.
In the CRL, the FDA stated that the application could not be approved in its present form and that an additional clinical trial would be required.
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.
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.
Investigators conducted a cohort study that compared adverse effects and outcomes among patients with community-acquired urinary tract infection treated with cotrimoxazole vs fluoroquinolones.
The double-blinded, placebo-controlled noninferiority study included a total of 272 afebrile men from 2 US Veterans Affairs medical centers.
The NDA submission was supported by data from the phase 3 SURE1 clinical trial.
In female nursing home residents, there was no significant effect on bacteriuria plus pyuria over 1 year in those receiving cranberry capsules.