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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Invasive Aspergillosis, Mucormycosis

Intervention / Treatment
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* Drug: Isavuconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Isavuconazole|antifungal agent|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of patients and their respective safety outcomes of treatment with isavuconazole | treatment related AEs and SAEs | up to 6 months post-index | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |