The relationship between the success rate of empirical antifungal therapy with intravenous itraconazole and clinical parameters, including plasma levels of itraconazole, in immunocompromised patients receiving itraconazole oral solution as prophylaxis: A multicenter, prospective, open-label, observational study in Korea

Jin Seok Kim, June Won Cheong, Yeo Kyeoung Kim, Jinny Park, Yeung Chul Mun, Hye Jin Kang, Hyeon Gyu Yi, Je Hwan Lee, Yang Soo Kim, Hun Mo Ryoo, Sung Hyun Kim, Ho Young Kim, Jin Young Kim, Dong Gun Lee, Hoon Gu Kim, Hawk Kim, Young Don Joo, Yoo Hong Min

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10 Scopus citations

Abstract

To identify the role of therapeutic drug monitoring of itraconazole (ITZ) in the setting of empirical antifungal therapy with intravenous (IV) ITZ, we performed a multicenter, prospective study in patients with hematological malignancies who had received antifungal prophylaxis with ITZ oral solution (OS). We evaluated the plasma levels of ITZ and hydroxy (OH) ITZ both before initiation of IV ITZ and on days 5-7 of IV ITZ. A total of 181 patients showed an overall success rate of 68.0 %. Prolonged baseline neutropenia and accompanying cardiovascular comorbidity were significantly associated with poor outcomes of the empirical antifungal therapy (P = 0.005 and P = 0.001, respectively). A significantly higher trough plasma level of OH ITZ per body weight was found in the patients who achieved success with empirical antifungal therapy (P = 0.036). There were no significant correlations between plasma concentrations of ITZ/OH ITZ (baseline or trough levels) and toxicities. Seven patients had a discontinuation of ITZ therapy due to toxicity. This study demonstrated that IV ITZ as empirical antifungal therapy was effective and therapeutic drug monitoring was helpful to estimate the outcome of empirical antifungal therapy in patients receiving antifungal prophylaxis with ITZ OS. To predict the outcome of empirical antifungal therapy with IV ITZ, we should evaluate baseline clinical characteristics and also perform the therapeutic drug monitoring of both ITZ and OH ITZ.

Original languageEnglish
Pages (from-to)33-42
Number of pages10
JournalAnnals of Hematology
Volume93
Issue number1
DOIs
StatePublished - Jan 2014

Bibliographical note

Funding Information:
Acknowledgments This work was supported in part by a grant from Janssen Korea, Seoul, South Korea. We thank all the nurses and doctors who were involved in caring for the patients.

Keywords

  • Empirical antifungal therapy
  • Hematological malignancy
  • Hydroxy itraconazole
  • Therapeutic drug monitoring
  • itraconazole

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