Efficacy and safety of 3 day versus 7 day cefditoren pivoxil regimens for acute uncomplicated cystitis: multicentre, randomized, open-label trial

J Antimicrob Chemother. 2017 Feb;72(2):529-534. doi: 10.1093/jac/dkw424. Epub 2016 Oct 12.

Abstract

Background: Fluoroquinolone-non-susceptible Escherichia coli isolated from patients with acute uncomplicated cystitis are a matter of increasing concern. Cefditoren pivoxil is an oral, β-lactamase-stable, extended-spectrum cephalosporin that is effective against fluoroquinolone-non-susceptible bacteria.

Objectives: To evaluate the clinical and microbiological efficacies of cefditoren pivoxil against acute uncomplicated cystitis and to determine the optimal duration of cefditoren pivoxil treatment.

Methods: We compared 3 and 7 day regimens of cefditoren pivoxil in a multicentre, randomized, open-label study.

Results: A total of 104 female patients with acute uncomplicated cystitis were enrolled and randomized into 3 day (n = 51) or 7 day (n = 53) treatment groups. At first visit, 94 bacterial strains were isolated from the 104 participants of which 81.7% (85/104) were E. coli. Clinical and microbiological efficacies were evaluated 5-9 days following administration of the final dose of cefditoren pivoxil. The clinical efficacies of the 3 and 7 day groups were 90.9% (40/44) and 93.2% (41/44), respectively (P = 1.000). The microbiological efficacies of the 3 and 7 day groups were 82.5% (33/40) and 90.2% (37/41), respectively (P = 0.349). There were no adverse events due to cefditoren pivoxil treatment, with the exception of a mild allergic reaction in one patient, after which the cefditoren pivoxil was exchanged for another antimicrobial.

Conclusions: Cefditoren pivoxil is safe and effective for uncomplicated cystitis, with no significant differences in clinical and microbiological efficacies between 3 and 7 day regimens.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Cephalosporins / administration & dosage*
  • Cephalosporins / adverse effects
  • Cephalosporins / therapeutic use*
  • Citrobacter koseri / drug effects
  • Citrobacter koseri / isolation & purification
  • Cystitis / drug therapy*
  • Cystitis / microbiology*
  • Drug Resistance, Bacterial
  • Enterococcus faecalis / drug effects
  • Enterococcus faecalis / isolation & purification
  • Escherichia coli / drug effects
  • Escherichia coli / isolation & purification
  • Escherichia coli Infections / drug therapy
  • Escherichia coli Infections / microbiology
  • Female
  • Fluoroquinolones / pharmacology
  • Humans
  • Klebsiella pneumoniae / drug effects
  • Klebsiella pneumoniae / isolation & purification
  • Microbial Sensitivity Tests
  • Middle Aged
  • Staphylococcus saprophyticus / drug effects
  • Staphylococcus saprophyticus / isolation & purification
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Cephalosporins
  • Fluoroquinolones
  • cefditoren pivoxil