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Clinical study on the efficacy and safety of intravenous itraconazole infusion for the treatment of invasive fungal infection in china.

Abstract
Itraconazole has a broad spectrum of activity against the most common fungal pathogens. Prior problems with absorption in severely ill patients have been overcome with the introduction of an oral solution and an intravenous preparation. An open-labeled, non-competitive, multicenter phase IV study was conducted to investigate the efficacy and safety of itraconazole administered intravenously for the treatment of invasive fungal infections in Chinese patients. Patients were treated with itraconazole intravenously for 2 weeks (200 mg twice daily for 2 days, then 200 mg once daily for 12 days) followed by 28 days of oral capsules (200 mg twice daily). Efficacy evaluation included an assessment of the clinical efficacy, fungal efficacy and total efficacy on days 14 and 42. Of 156 evaluable patients, 35 patients had proven and 62 suspected invasive fungal infections, and 59 patients were treated empirically. On day 14 the total efficacy rate in patients with proven infection was 54.3% (19/35; 95% confidence interval [CI], 37-71%) and on day 42 it was 65.7% (23/35; 95% CI, 48-81%). The most common adverse events were hypokalemia (13.5%), gastrointestinal disorders (12.8%), elevation of liver enzymes (10.9%) and increase of bilirubin (8.3%). Itraconazole intravenously followed by oral capsules is thus tolerated and effective in severely ill patients with proven invasive fungal infection.
AuthorsAixia Wang, Yingyuan Zhang, Lixian He, Zhixiang Shen, Wanqing Liao, Mingzhe Han, Ruoyu Li, Derong Liang, Shaoxi Wu, Corinna Hahn-Ast, Axel Glasmacher, Wai Albert Liekwok
JournalJapanese journal of infectious diseases (Jpn J Infect Dis) Vol. 59 Issue 6 Pg. 370-6 (Dec 2006) ISSN: 1344-6304 [Print] Japan
PMID17186955 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Antifungal Agents
  • Itraconazole
Topics
  • Adolescent
  • Adult
  • Aged
  • Antifungal Agents (administration & dosage, adverse effects, therapeutic use)
  • China
  • Female
  • Hospitalization
  • Humans
  • Infusions, Intravenous
  • Itraconazole (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Middle Aged
  • Mitosporic Fungi (classification, drug effects, isolation & purification)
  • Mycoses (drug therapy, microbiology)
  • Treatment Outcome

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