A randomized clinical trial to compare fleroxacin-rifampicin with flucloxacillin or vancomycin for the treatment of staphylococcal infection

Clin Infect Dis. 2004 Nov 1;39(9):1285-92. doi: 10.1086/424506. Epub 2004 Oct 11.

Abstract

Background: Oral combination therapy with fluoroquinolones plus rifampicin is a promising alternative to standard parenteral therapy for staphylococcal infections.

Methods: In a multicenter, randomized trial, we compared the efficacy, safety, and length of hospital stay for patients with staphylococcal infections treated either with an oral combination of a fluoroquinolone (fleroxacin) plus rifampicin or with standard parenteral treatment (flucloxacillin or vancomycin). Patients were included if cultures showed the presence of bacteremia or deep-seated infections with Staphylococcus aureus (104 patients) or catheter-related bacteremia due to drug-susceptible, coagulase-negative staphylococci (23 patients).

Results: The cure rate in the intention-to-treat analysis was 78% for the fleroxacin-rifampicin group (68 patients) and 75% for the standard therapy group (59 patients; 47 received flucloxacillin, and 12 received vancomycin); in the population of clinically evaluable patients (n=119), the cure rate was 82% and 80%, respectively; and in the population of microbiologically evaluable patients (n=103), the cure rate was 86% and 84%, respectively. Clinical and bacteriological failures after S. aureus infections were documented in similar proportions of patients. The median length of hospital stay after study entry was 12 days in the fleroxacin-rifampicin group, compared with 23 days in the standard treatment group (P=.006). More adverse events probably related to the study drug were reported in the fleroxacin-rifampicin group than in the standard therapy group (15 of 68 vs. 5 of 59 patients; P=.05).

Conclusions: This study suggests that an oral regimen containing a fluoroquinolone plus rifampicin may be effective for treating staphylococcal infections, allowing earlier discharge from the hospital.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Bacteremia / drug therapy
  • Catheters, Indwelling / microbiology
  • Drug Therapy, Combination
  • Female
  • Fleroxacin / administration & dosage
  • Fleroxacin / adverse effects
  • Fleroxacin / therapeutic use*
  • Floxacillin / administration & dosage
  • Floxacillin / adverse effects
  • Floxacillin / therapeutic use*
  • Humans
  • Male
  • Methicillin Resistance / drug effects
  • Middle Aged
  • Prospective Studies
  • Rifampin / administration & dosage
  • Rifampin / adverse effects
  • Rifampin / therapeutic use*
  • Safety
  • Staphylococcal Infections / diagnosis
  • Staphylococcal Infections / drug therapy*
  • Staphylococcal Infections / metabolism
  • Staphylococcus / drug effects
  • Staphylococcus / isolation & purification
  • Staphylococcus aureus / drug effects
  • Staphylococcus aureus / isolation & purification
  • Treatment Outcome
  • Vancomycin / administration & dosage
  • Vancomycin / adverse effects
  • Vancomycin / therapeutic use*

Substances

  • Floxacillin
  • Vancomycin
  • Fleroxacin
  • Rifampin