Cefpodoxime vs ciprofloxacin for short-course treatment of acute uncomplicated cystitis: a randomized trial.
BACKGROUND
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.


METHODS
Randomized, double-blind trial of 300 women aged 18 to 55 years with acute uncomplicated cystitis comparing ciprofloxacin (n = 150) with cefpodoxime (n = 150); patients were from a student health center in Seattle, Washington, and a referral center in Miami, Florida. The study was conducted from 2005 to 2009 and outcomes were assessed at 5 to 9 days and 28 to 30 days after completion of therapy. Intent-to-treat and per-protocol analyses were performed; 15 women in the ciprofloxacin group and 17 women in the cefpodoxime group were lost to follow-up.


METHODS
Patients were given 250 mg of ciprofloxacin orally twice daily for 3 days or 100 mg of cefpodoxime proxetil orally twice daily for 3 days.


METHODS
Overall clinical cure (defined as not requiring antimicrobial treatment during follow-up) at the 30-day follow-up visit. Secondary outcomes were clinical and microbiological cure at the first follow-up visit and vaginal Escherichia coli colonization at each follow-up visit. The hypothesis that cefpodoxime would be noninferior to ciprofloxacin by a 10% margin (ie, for the difference in the primary outcome for ciprofloxacin minus cefpodoxime, the upper limit of the confidence interval would be <10%) was formulated prior to data collection.


RESULTS
The overall clinical cure rate at the 30-day visit with the intent-to-treat approach in which patients lost to follow-up were considered as having clinical cure was 93% (139/150) for ciprofloxacin compared with 82% (123/150) for cefpodoxime (difference of 11%; 95% CI, 3%-18%); and for the intent-to-treat approach in which patients lost to follow-up were considered as having not responded to treatment, the clinical cure rate was 83% (124/150) for ciprofloxacin compared with 71% (106/150) for cefpodoxime (difference of 12%; 95% CI, 3%-21%). The microbiological cure rate was 96% (123/128) for ciprofloxacin compared with 81% (104/129) for cefpodoxime (difference of 15%; 95% CI, 8%-23%). At first follow-up, 16% of women in the ciprofloxacin group compared with 40% of women in the cefpodoxime group had vaginal E coli colonization.


CONCLUSIONS
Among women with uncomplicated cystitis, a 3-day regimen of cefpodoxime compared with ciprofloxacin did not meet criteria for noninferiority for achieving clinical cure. These findings, along with concerns about possible adverse ecological effects associated with other broad-spectrum β-lactams, do not support the use of cefpodoxime as a first-line fluoroquinolone-sparing antimicrobial for acute uncomplicated cystitis.


BACKGROUND
clinicaltrials.gov Identifier: NCT00194532.
Department of Medicine, School of Medicine, University of Miami, Miami, Florida 33136, USA. thooton@med.miami.edu
Thomas M
TM
Hooton
Pacita L
PL
Roberts
Ann E
AE
Stapleton
D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D015296:Ceftizoxime / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D003556:Cystitis / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004352:Drug Resistance, Microbial; D004926:Escherichia coli / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D005260:Female; D006801:Humans; D016896:Treatment Outcome; D014621:Vagina / Q000382:microbiology; D055815:Young Adult; D000097623:Cefpodoxime
D000900:Anti-Bacterial Agents; D015296:Ceftizoxime; D002939:Ciprofloxacin; D000097623:Cefpodoxime