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CRESEMBA® in Mucormycosis: Study Design

The VITAL trial was undertaken to assess the efficacy and safety of isavuconazole for the treatment of mucormycosis and to compare its efficacy with amphotericin B in a matched case-control analysis.1*

Primary endpoint

Efficacy:

  • Overall response at Day 42 assessed by a data review committee

Secondary endpoints

Efficacy:

  • Assessments of overall, clinical, radiological and mycological responses at Day 42, Day 84 and end of treatment
  • Crude and weighted mortality at Days 42 and 84
  • Matched case-control analysis using the FungiScope: Global Emerging Fungal Infection Registry for Day 42 crude all-cause mortality

Oral or intravenous loading regimen determined at the discretion of local investigators.
EOT, end of treatment; IV, intravenous; od, once daily; PO, orally; q8h, every 8 hours; q24h, every 24 hours.

*The VITAL study is the first trial to show the efficacy and safety of CRESEMBA for the treatment of mucormycosis, either when given for primary treatment, for refractory disease, or as an alternative in patients intolerant to amphotericin B. 
Mucormycosis is an extremely rare disease which means that recruiting the numbers of patients needed for randomised controlled trials is impractical. For these reasons, the VITAL study was designed as an open-label, uncontrolled trial. To put the all-cause mortality rates and overall response rates from VITAL into context, the US FDA and the European EMA CHMP requested additional analyses in the context of external control data. As a result, a matched case-control analysis using contemporaneous controls from the FungiScope database was also performed. This case-control analysis showed CRESEMBA has similar efficacy compared with primary amphotericin B-based treatment.

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Dosing

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References:
  1. ​​​​​​​Marty FM, Ostrosky-Zeichner L, Cornely OA, et al. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016;16(7):828–837.
PP-CRB-GBR-1207. August 2021

Mucormycosis (Quick Links)

Safety Profile

 CRESEMBA safety information

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PP-PFE-GBR-2688. December 2020

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