Randomized trial of trovafloxacin and ofloxacin for single-dose therapy of gonorrhea. Trovafloxacin Gonorrhea Study Group

Am J Med. 1998 Jan;104(1):28-32. doi: 10.1016/s0002-9343(97)00277-5.

Abstract

Purpose: To compare trovafloxacin, a new quinolone antibiotic with enhanced activity against Neisseria gonorrhoeae, with ofloxacin as single-dose oral therapy for uncomplicated gonococcal urethritis or cervicitis.

Patients and methods: In this multicenter, double-blind trial, 625 patients (270 men, 355 women) with uncomplicated gonococcal urethritis or cervicitis received one 100-mg tablet of trovafloxacin or two 200-mg capsules of ofloxacin as a single dose under direct supervision.

Results: Single-dose oral therapy with trovafloxacin was equivalent both bacteriologically and clinically to ofloxacin. Among evaluable patients, N gonorrhoeae was eradicated in 99% of trovafloxacin recipients and in 98% of ofloxacin recipients. Each treatment was well tolerated; vaginitis was the most frequently observed side effect (4% trovafloxacin, 7% ofloxacin).

Conclusion: Based on the results presented here, trovafloxacin is a promising agent for single-dose therapy of uncomplicated gonorrhea.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Anti-Infective Agents / administration & dosage
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Fluoroquinolones*
  • Gonorrhea / drug therapy*
  • Humans
  • Male
  • Naphthyridines / administration & dosage
  • Naphthyridines / adverse effects
  • Naphthyridines / therapeutic use*
  • Neisseria gonorrhoeae / drug effects*
  • Ofloxacin / administration & dosage
  • Ofloxacin / adverse effects
  • Ofloxacin / therapeutic use*
  • Treatment Outcome
  • Urethritis / drug therapy*
  • Uterine Cervicitis / drug therapy*

Substances

  • Anti-Infective Agents
  • Fluoroquinolones
  • Naphthyridines
  • trovafloxacin
  • Ofloxacin