A randomized, double-blind comparison of itraconazole oral solution and fluconazole tablets in the treatment of esophageal candidiasis

J Infect Dis. 1997 Jul;176(1):227-32. doi: 10.1086/514028.

Abstract

This multicenter, randomized, double-blind study compared the efficacy and safety of itraconazole oral solution and fluconazole tablets in the treatment of esophageal candidiasis. One hundred twenty-six immunocompromised patients with esophageal candidiasis were treated with itraconazole oral solution or fluconazole tablets (both at 100-200 mg) once daily for 3-8 weeks, for 2 weeks beyond the resolution of symptoms, and were then followed for 4 more weeks. Severity of symptoms was assessed weekly during treatment and every 2 weeks during follow-up. Patients treated with itraconazole oral solution had a rate of clinical response (cured or improved) comparable to that of patients treated with fluconazole (94% vs. 91%). The mycologic eradication rate was 92% for itraconazole and 78% for fluconazole. Both treatments were well tolerated. Results from treatment with once-daily itraconazole oral solution was clinically comparable to those with fluconazole and is an alternative for the treatment of esophageal candidiasis in immunocompromised patients.

Publication types

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

MeSH terms

  • Administration, Oral
  • Adult
  • Antifungal Agents / administration & dosage*
  • Candidiasis / drug therapy*
  • Double-Blind Method
  • Esophageal Diseases / drug therapy*
  • Female
  • Fluconazole / administration & dosage*
  • Fluconazole / adverse effects
  • Humans
  • Itraconazole / administration & dosage*
  • Itraconazole / adverse effects
  • Male
  • Middle Aged
  • Recurrence
  • Solutions
  • Tablets

Substances

  • Antifungal Agents
  • Solutions
  • Tablets
  • Itraconazole
  • Fluconazole