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Orlynvah is approved for uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis. The FDA approved sulopenem etzadroxil and probenecid Orlynvah; Iterum Therapeutics for the treatment of uncomplicated urinary tract infections uUTIs caused by Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women with limited or no alternative oral antibacterial option. In the SURE 1 NCT trial, investigators used a randomized, multicenter, double-blinded design that compared the oral drug with oral ciprofloxacin, according to the study authors.
The study was conducted from August through January at centers in 4 counties. Patients received randomized treatment in a ratio, with those receiving sulopenem etzadroxil and probenecid taking the table twice daily for 5 days and those receiving ciprofloxacin taking it twice daily for 3 days.
The primary end point was overall response, and additional endpoints included clinical response on day 12, overall and clinical responses at the end of treatment and the final visit on day 28, and adverse events. The results showed that sulopenem etzadroxil and probenecid was superior at Additionally, in susceptible populations, investigators found that the drug was not noninferior at Diarrhea was reported more frequently with the study drug at Clinical success and microbiological success were Patients received either the study drug twice daily for 5 days or amoxicillin and clavulanic acid twice daily for 5 days.
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