Registry of Patients Treated With Systemic Mold-Active Triazoles

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

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).

Study Overview

• Status: Completed
• Conditions: Invasive Fungal Infection
• Intervention / Treatment: Drug: Isavuconazonium sulfate; Drug: Voriconazole; Drug: Posaconazole

• Study Type: Observational
• Enrollment (Actual): 2015

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama - Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • Davis, California, United States, 95616
      • University of California
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine
    • Palo Alto, California, United States, 94305
      • Stanford Health Care
    • Sylmar, California, United States, 91342
      • Olive View UCLA Medical Center
    • Torrance, California, United States, 90502
      • LA BioMed
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60660
      • Loyola University
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Cancer Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
    • Saint Louis, Missouri, United States, 63110
      • Washington University St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Somerville, New Jersey, United States, 08876
      • Robert Wood Johnson University Hospital Somerset
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Lima, Ohio, United States, 45801
      • Regional Infectious Disease and Infusion Center, Inc.
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Good Samaritan Hospital
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Rhode Island Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Childrens Research Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Health System
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients on a mold-active triazole

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Isavuconazonium sulfate Group; Oral and Intravenous	Drug: Isavuconazonium sulfate; Oral and Intravenous; Other Names: Cresemba
Voriconazole Group; Oral and Intravenous	Drug: Voriconazole; Oral and Intravenous; Other Names: Vfend
Posaconazole Group; Oral and Intravenous	Drug: Posaconazole; Oral and intravenous; Other Names: Noxafil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Actual): April 24, 2020
• Study Completion (Actual): April 24, 2020

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: mold-active triazoles
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; 14-alpha Demethylase Inhibitors; Trypanocidal Agents; Posaconazole; Isavuconazole; Voriconazole
• Other Study ID Numbers: 9766-MA-3034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas".