Registry of Patients Treated With Systemic Mold-Active Triazoles

Study Overview
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Brief Summary
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The purpose of this study is to describe representative real-world patterns of care for the management of invasive fungal infections (IFIs), including invasive mold infection (IMI). Specifically, the study goals are to examine real world patient characteristics and treatment patterns, associated healthcare resource utilization, and outcomes associated with use of mold-active triazoles (MATs) to treat invasive fungal infections (IFIs).

Official Title
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Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles

Conditions
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Invasive Fungal Infection

Intervention / Treatment
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* Drug: Isavuconazonium sulfate
* Drug: Voriconazole
* Drug: Posaconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (ISAV), voriconazole (VORI), posaconazole (POSA). Exclusion Criteria: Currently enrolled in any clinical trial with an investigational antifungal agent. Individuals who subsequently enroll in an investigational antifungal study will be discontinued and data collected up to the time of investigational product will be evaluable. Patients who died before entering the study. Patients who previously participated in this registry.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Isavuconazonium sulfate Group<br>Oral and Intravenous | Drug: Isavuconazonium sulfate<br>* Oral and Intravenous<br>* Other names: Cresemba;|
| Voriconazole Group<br>Oral and Intravenous | Drug: Voriconazole<br>* Oral and Intravenous<br>* Other names: Vfend;|
| Posaconazole Group<br>Oral and Intravenous | Drug: Posaconazole<br>* Oral and intravenous<br>* Other names: Noxafil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment patterns of care assessed by reason for therapy | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by category of diagnosis at time of therapy initiation | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by onset of treatment/prophylaxis | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by length of treatment/prophylaxis | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by use of diagnostic method(s) | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by type of diagnostic method(s) used | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by use of therapeutic drug monitoring (TDM) | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by occurrence of drug-drug interactions (DDI) | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by the sequence of invasive fungal infection treatment (IFI) | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Treatment patterns of care assessed by discontinuation due to adverse events (AEs) or other reasons | Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall. | 5 years | 
| Patient characteristics assessed by underlying host/risk factors | The summaries of patient characteristics will be by MAT treatment at baseline and overall. | 5 years | 
| Patient characteristics assessed by patient baseline characteristics | The summaries of patient characteristics will be by MAT treatment at baseline and overall. | 5 years | 
| Patient characteristics assessed by fungal disease diagnosis | The summaries of patient characteristics will be by MAT treatment at baseline and overall. | 5 years | 
| Patient characteristics assessed by pathogen treated | The summaries of patient characteristics will be by MAT treatment at baseline and overall. | 5 years | 
| Patient characteristics assessed by pathogen susceptibility | The summaries of patient characteristics will be by MAT treatment at baseline and overall. | 5 years | 
| Patient characteristics assessed by site of fungal infection | The summaries of patient characteristics will be by MAT treatment at baseline and overall. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall healthcare resource utilization assessed by hospitalization length of stay (LOS) | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU) | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by time spent on ventilator in ICU | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM) | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by incidence of discharge to a skilled nursing facility (SNF) or long term care (LTC) facility | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by incidence of hospital readmissions at 30 and 90 days within a 5-year period | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by duration of hospital readmissions at 30 and 90 days within a 5-year period | Assessments of overall healthcare resource inpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by outpatient utilization | Number of ED visits during the follow-up period | 5 years | 
| Overall healthcare resource utilization assessed by frequency of outpatient visits within 30 and 90 days within a 5-year period | Assessments of overall healthcare resource outpatient utilization will be summarized | 5 years | 
| Overall healthcare resource utilization assessed by primary reason for outpatient office visits within 30 and 90 days within a 5-year period | Assessments of overall healthcare resource outpatient utilization will be summarized | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mold-active triazoles