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The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial.

Publication ,  Journal Article
Spellberg, B; Ibrahim, AS; Chin-Hong, PV; Kontoyiannis, DP; Morris, MI; Perfect, JR; Fredricks, D; Brass, EP
Published in: J Antimicrob Chemother
March 2012

OBJECTIVES: Host iron availability is fundamental to mucormycosis pathogenesis. The combination of liposomal amphotericin B (LAmB) and deferasirox iron chelation therapy synergistically improved survival in diabetic mice with mucormycosis. To determine the safety of combination deferasirox plus LAmB therapy for mucormycosis, a multicentred, placebo-controlled, double-blinded clinical trial was conducted. METHODS: Twenty patients with proven or probable mucormycosis were randomized to receive treatment with LAmB plus deferasirox (20 mg/kg/day for 14 days) or LAmB plus placebo (NCT00419770, clinicaltrials.gov). The primary analyses were for safety and exploratory efficacy. RESULTS: Patients in the deferasirox arm (n=11) were more likely than those in the placebo arm (n=9) to have active malignancy, neutropenia and corticosteroid therapy, and were less likely to receive concurrent non-study antifungal therapy. Reported adverse events and serious adverse events were similar between the groups. However, death was more frequent in the deferasirox than in the placebo arm at 30 days (45% versus 11%, P=0.1) and 90 days (82% versus 22%, P=0.01). Global success (alive, clinically stable, radiographically improved) for the deferasirox arm versus the placebo arm at 30 and 90 days, respectively, was 18% (2/11) versus 67% (6/9) (P=0.06) and 18% (2/11) versus 56% (5/9) (P=0.2). CONCLUSIONS: Patients with mucormycosis treated with deferasirox had a higher mortality rate at 90 days. Population imbalances in this small Phase II study make generalizable conclusions difficult. Nevertheless, these data do not support a role for initial, adjunctive deferasirox therapy for mucormycosis.

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Published In

J Antimicrob Chemother

DOI

EISSN

1460-2091

Publication Date

March 2012

Volume

67

Issue

3

Start / End Page

715 / 722

Location

England

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Survival Analysis
  • Placebos
  • Mucormycosis
  • Middle Aged
  • Microbiology
  • Mice
  • Male
  • Iron Chelating Agents
 

Citation

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Spellberg, B., Ibrahim, A. S., Chin-Hong, P. V., Kontoyiannis, D. P., Morris, M. I., Perfect, J. R., … Brass, E. P. (2012). The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial. J Antimicrob Chemother, 67(3), 715–722. https://doi.org/10.1093/jac/dkr375
Spellberg, Brad, Ashraf S. Ibrahim, Peter V. Chin-Hong, Dimitrios P. Kontoyiannis, Michele I. Morris, John R. Perfect, David Fredricks, and Eric P. Brass. “The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial.J Antimicrob Chemother 67, no. 3 (March 2012): 715–22. https://doi.org/10.1093/jac/dkr375.
Spellberg B, Ibrahim AS, Chin-Hong PV, Kontoyiannis DP, Morris MI, Perfect JR, et al. The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial. J Antimicrob Chemother. 2012 Mar;67(3):715–22.
Spellberg, Brad, et al. “The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial.J Antimicrob Chemother, vol. 67, no. 3, Mar. 2012, pp. 715–22. Pubmed, doi:10.1093/jac/dkr375.
Spellberg B, Ibrahim AS, Chin-Hong PV, Kontoyiannis DP, Morris MI, Perfect JR, Fredricks D, Brass EP. The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial. J Antimicrob Chemother. 2012 Mar;67(3):715–722.
Journal cover image

Published In

J Antimicrob Chemother

DOI

EISSN

1460-2091

Publication Date

March 2012

Volume

67

Issue

3

Start / End Page

715 / 722

Location

England

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Survival Analysis
  • Placebos
  • Mucormycosis
  • Middle Aged
  • Microbiology
  • Mice
  • Male
  • Iron Chelating Agents