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Cresemba in Invasive Aspergillosis: Study Design

The SECURE trial was undertaken to compare the efficacy and safety of intravenous and oral formulations of isavuconazole to voriconazole for the primary treatment of invasive aspergillosis.

Primary endpoint1

Efficacy:

  • All-cause mortality from first dose of study drug to Day 42 in the ITT population​​​​​​​

Secondary endpoints

Efficacy:

  • Overall response at end of treatment in the mITT population

Other Secondary endpoints:

  • All-cause mortality from first dose of study drug to Day 84
  • Overall clinical, mycological and radiological responses on Day 42, 84 and end of treatment
  • Safety
  • Tolerability

* Hepatic dysfunction (bilirubin ≥3 × ULN, alanine transaminase or aspartate transaminase ≥5 × ULN, cirrhosis or chronic hepatic failure), or moderate-to-severe renal dysfunction (calculated creatinine clearance <50 mL/min). †As assessed by the data review committee. ITT, intention-to-treat; IV, intravenous; mITT, modified intention-to-treat; PO, orally; q8h, every 8 hours; q12h, every 12 hours; q24h every 24 hours; ULN- upper limit of normal

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Dosing

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References:
  1. ​​​​​​​Maertens JA, Raad II, Marr KA, et al. Isavuconazole versus voricanazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE); a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016;387(10020):760–769.
PP-CRB-GBR-1202. August 2021

Invasive Aspergillosis (Quick Links)

Safety Profile

 CRESEMBA safety information

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PP-PFE-GBR-2688. December 2020

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