Real World Evidence of Cresemba use in Europe
Research type
Research Study
Full title
Patterns of Real-World Isavuconazole use, Effectiveness, Safety, and Healthcare Resource Utilization—a Retrospective Chart Review Study of Patients With Mucormycosis or Invasive Aspergillosis (PRISMA)
IRAS ID
286402
Contact name
Mónica Inês
Contact email
Sponsor organisation
Pfizer Inc.
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
A retrospective, observational cohort study involving the abstraction of data from the medical records of patients diagnosed with invasive aspergillosis or invasive mucormycosis who initiated isavuconazole therapy between October 15, 2015 and June 30, 2019.
The study aims to document how isavuconazole is used in 5 European countries (England, Spain, France, Italy, and Germany) alongside clinical outcomes and safety. Further, the study aims to document demographic and clinical characteristics of these patients and the health care resource use (e.g., clinic visits and hospitalizations).
The target sample size is 600 patients across 22 sites in Europe: 4 of these sites will be in England. Patient medical records will be accessed only by NHS staff who have permission to access this data as part of their clinical or administrative role. These staff will enter particular pieces of data from the medical record on to an electronic data collection form designed specifically for this study. The data collection form will only allow for anonymized data (i.e., none of the data will be personally identifiable or could be linked back to an individual patient in any way).REC name
London - Fulham Research Ethics Committee
REC reference
20/PR/0939
Date of REC Opinion
16 Feb 2021
REC opinion
Further Information Favourable Opinion