Patterns of Real-World Isavuconazole Use - a Study of Patients With Mucormycosis or Invasive Aspergillosis

Invasive Aspergillosis Clinical Trial

— PRISMA  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550936
• Other study ID #: C3791008
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: December 23, 2023

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This observational study will include approximately 600 patients diagnosed with invasive aspergillosis or mucormycosis who received treatment with at least one dose of isavuconazole in the hospital setting.

Patients will be recruited in approximately 20 sites across 5 countries in Europe. Patients will be followed from isavuconazole initiation (index event) until six-months post-index treatment discontinuation, death, loss to follow-up, or 31 December, 2019, whichever occurs first.

De-identified data on patient demographics, disease characteristics, treatment effectiveness, safety outcomes, isavuconazole treatment patterns, and HCRU will be collected from patient medical records and entered into an electronic data capture (EDC) system by site staff. Follow-up data will include details of treatment over time and clinical, radiological, mycological, and healthcare resource utilization outcomes. As this study is retrospective, information pertaining to patient care will already be documented in patient medical records at the time of chart abstraction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: December 23, 2023
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Hospitalized patient must be aged = 18 years at the time of isavuconazole initiation

2. 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 )

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

Exclusion Criteria:

1. Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis
• Mucormycosis
• Zygomycosis

Intervention

Drug:
• Isavuconazole
antifungal agent

Locations

Country	Name	City	State
France	Hôpital Huriez CHU de Lille	Lille
France	CHU de Limoges	Limoges
France	Paris University	Paris
France	Institut de Cancérologie	Strasbourg
Germany	University Hospital of Cologne	Cologne
Germany	Universitätsklinik Frankfurt	Frankfurt
Germany	Klinikum rechts der Isar Technische Universität München	Munich
Germany	Comprehensive Cancer Center Ulm (CCCU)	Ulm
Italy	Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino	Turin	Piedmont
Spain	Fundació Clínic Per A La Recerca Biomèdica	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	University Hospital Miguel Servet	Zaragoza
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	King'S College Hospital Nhs Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients and their respective clinical outcomes of treatment with isavuconazole	overall response, including clinical response, mycological response, radiological response, and mortality	up to 6 months post-index
Primary	Proportion of patients and their respective safety outcomes of treatment with isavuconazole	treatment related AEs and SAEs	up to 6 months post-index
Secondary	Proportion of patients for each indication and usage pattern of isavuconazole	formulation, dosage (loading and maintenance), duration, treatment changes (including dosage adjustments, switching, and discontinuation), and concomitant medication	up to 6 months post-index
Secondary	Proportion of patients and their respective healthcare resource utilization after treatment with isavuconazole	length of stay [LOS], emergency room [ER] visits, intensive care unit [ICU] visits and LOS, inpatient hospitalizations, and planned and unplanned outpatient visits	up to 6 months post-index

External Links

•   To obtain contact information for a study center near you, click here.