Cefpodoxime vs Ciprofloxacin for Short-Course Treatment of Acute Uncomplicated Cystitis

作者: Thomas M. Hooton , Pacita L. Roberts , Ann E. Stapleton

DOI: 10.1001/JAMA.2012.80

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摘要: Context Although fluoroquinolones remain the most reliable urinary antimicrobial, resistance rates have increased and effective fluoroquinolone-sparing antimicrobials are needed. Objective To determine whether cefpodoxime is noninferior to ciprofloxacin for treatment of acute cystitis. Design, Setting, Patients Randomized, double-blind trial 300 women aged 18 55 years with uncomplicated cystitis comparing (n = 150) (n = 150); patients were from a student health center in Seattle, Washington, referral Miami, Florida. The study was conducted 2005 2009 outcomes assessed at 5 9 days 28 30 after completion therapy. Intent-to-treat per-protocol analyses performed; 15 group 17 lost follow-up. Interventions given 250 mg orally twice daily 3 or 100 proxetil days. Main Outcome Measures Overall clinical cure (defined as not requiring antimicrobial during follow-up) 30-day follow-up visit. Secondary microbiological first visit vaginal Escherichia coli colonization each hypothesis that would be by 10% margin (ie, difference primary outcome minus cefpodoxime, upper limit confidence interval Results overall rate intent-to-treat approach which considered having 93% (139/150) compared 82% (123/150) (difference 11%; 95% CI, 3%-18%); responded treatment, 83% (124/150) 71% (106/150) 12%; 3%-21%). 96% (123/128) 81% (104/129) 15%; 8%-23%). At follow-up, 16% 40% had E colonization. Conclusions Among cystitis, 3-day regimen did meet criteria noninferiority achieving cure. These findings, along concerns about possible adverse ecological effects associated other broad-spectrum β-lactams, do support use first-line Trial Registration clinicaltrials.gov Identifier: NCT00194532

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