Moxifloxacin versus amoxicillin clavulanate in the treatment of acute maxillary sinusitis: a primary care experience

Int J Clin Pract. 2001 Jun;55(5):309-15.

Abstract

In this prospective, multicentre, randomised, non-blinded phase III clinical trial, 475 adult patients with acute sinusitis received a 10-day oral regimen of either moxifloxacin (400 mg once daily) or amoxicillin clavulanate (875 mg twice daily). The primary measure of efficacy was clinical resolution. Secondary outcome measures included clinical relapse at follow-up and evaluation of patient reported outcomes. Of 471 adults comprising the intent-to-treat population (234 moxifloxacin, 237 amoxicillin/clavulanate), moxifloxacin treatment was statistically equivalent to amoxicillin/clavulanate at the test-of-cure visit (85% vs 82%; 95% CI -6%, 13%). Analysis of the efficacy evaluable population, confirmed statistical equivalence (86% vs 84%; 95% CI -7%, 13%). Of note, by day 3 of treatment, significantly more moxifloxacin-treated patients (n = 47; 24%), than amoxicillin/clavulanate-treated patients (n = 28; 14%), reported feeling better (p < 0.02). Frequency of drug-related adverse events were similar between groups: nausea (11% moxifloxacin, 5% amoxicillin/clavulanate) and diarrhoea (3% moxifloxacin, 10% amoxicillin clavulanate). In conclusion, once-daily moxifloxacin is as effective and safe as twice-daily amoxicillin/clavulanate in the treatment of acute sinusitis. Moxifloxacin is associated with more rapid symptomatic relief.

Publication types

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

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin-Potassium Clavulanate Combination / administration & dosage*
  • Amoxicillin-Potassium Clavulanate Combination / adverse effects
  • Anti-Infective Agents / administration & dosage*
  • Anti-Infective Agents / adverse effects
  • Aza Compounds*
  • Drug Therapy, Combination / administration & dosage*
  • Drug Therapy, Combination / adverse effects
  • Female
  • Fluoroquinolones*
  • Humans
  • Male
  • Maxillary Sinusitis / drug therapy*
  • Middle Aged
  • Moxifloxacin
  • Prospective Studies
  • Quinolines*
  • Treatment Outcome

Substances

  • Anti-Infective Agents
  • Aza Compounds
  • Fluoroquinolones
  • Quinolines
  • Amoxicillin-Potassium Clavulanate Combination
  • Moxifloxacin