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)

Status: Completed
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Eligible patients are adults who have been treated with isavuconazole in routine practice at participating sites since 15 October, 2015 or since the date of launch in the country if it is after 15 October, 2015 until 30 June, 2019. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation

• Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed )

• Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)

Locations
Other Locations
France
CHU de Limoges
Limoges
Paris University
Paris
Institut de Cancérologie
Strasbourg
Germany
University Hospital of Cologne
Cologne
Universitätsklinik Frankfurt
Frankfurt
Klinikum rechts der Isar Technische Universität München
Munich
Comprehensive Cancer Center Ulm (CCCU)
Ulm
Italy
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Turin
Spain
Fundació Clínic Per A La Recerca Biomèdica
Barcelona
Vall d'Hebron University Hospital
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Marques de Valdecilla
Santander
University Hospital Miguel Servet
Zaragoza
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge
King'S College Hospital Nhs Foundation Trust
London
Time Frame
Start Date: 2021-03-10
Completion Date: 2023-12-23
Participants
Target number of participants: 307
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov