Clinical and bacteriological efficacy of 5-day telithromycin in acute maxillary sinusitis: a pooled analysis

J Infect. 2005 Apr;50(3):210-20. doi: 10.1016/j.jinf.2004.05.014.

Abstract

Objectives: To compare the efficacy and tolerability of a 5-day course of telithromycin (800 mg once daily) with a 10-day course of telithromycin or standard comparators (amoxicillin-clavulanate 500/125 mg three times daily or cefuroxime axetil 250 mg twice daily) in patients with acute maxillary sinusitis (AMS).

Methods: Data from three randomised double blind studies were pooled. The studies included patients with clinical symptoms of AMS and sinus X-ray findings of total opacity, air-fluid levels or mucosal thickening.

Results: Pooled analysis of results for 5-day telithromycin revealed overall clinical cure rates of 83.6% (383/458 patients) at post-therapy (days 17-24) and 78.9% (330/418 patients) at late post-therapy (days 31-45) in the per-protocol population. Clinical cure rates at post-therapy were equivalent to those observed with 10-day telithromycin (82.5% vs 81.7%) or comparator treatment (80.9% vs 77.4%). Moreover, clinical cure rates exceeded 80% in subgroups of patients of interest, including those with severe infection and those fulfilling more stringent criteria for bacterial AMS. A satisfactory bacteriological outcome was achieved in 87.6% of patients. The 5-day telithromycin regimen was well tolerated.

Conclusions: Telithromycin once daily for 5 days offers effective treatment for AMS and is comparable to 10-day courses of standard treatments.

Publication types

  • Comparative Study

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Amoxicillin-Potassium Clavulanate Combination / therapeutic use
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Cefuroxime / analogs & derivatives*
  • Cefuroxime / therapeutic use
  • Drug Administration Schedule
  • Drug Resistance, Bacterial
  • Female
  • Humans
  • Ketolides / administration & dosage
  • Ketolides / adverse effects
  • Ketolides / therapeutic use*
  • Male
  • Maxillary Sinusitis / drug therapy*
  • Maxillary Sinusitis / microbiology
  • Middle Aged

Substances

  • Anti-Bacterial Agents
  • Ketolides
  • Amoxicillin-Potassium Clavulanate Combination
  • telithromycin
  • Cefuroxime
  • cefuroxime axetil