Registry of Patients Treated With Systemic Mold-Active Triazoles
- Conditions
- Invasive Fungal Infection
- Interventions
- Registration Number
- NCT03066011
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2015
- Patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (ISAV), voriconazole (VORI), posaconazole (POSA).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Isavuconazonium sulfate Group Isavuconazonium sulfate Oral and Intravenous Voriconazole Group Voriconazole Oral and Intravenous Posaconazole Group Posaconazole Oral and Intravenous
- Primary Outcome Measures
Name Time Method Treatment patterns of care assessed by category of diagnosis at time of therapy initiation 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by reason for therapy 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by onset of treatment/prophylaxis 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by use of therapeutic drug monitoring (TDM) 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by occurrence of drug-drug interactions (DDI) 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by discontinuation due to adverse events (AEs) or other reasons 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Patient characteristics assessed by underlying host/risk factors 5 years The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by patient baseline characteristics 5 years The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by fungal disease diagnosis 5 years The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by pathogen susceptibility 5 years The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Treatment patterns of care assessed by length of treatment/prophylaxis 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by use of diagnostic method(s) 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by type of diagnostic method(s) used 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by the sequence of invasive fungal infection treatment (IFI) 5 years Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Patient characteristics assessed by pathogen treated 5 years The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by site of fungal infection 5 years The summaries of patient characteristics will be by MAT treatment at baseline and overall.
- Secondary Outcome Measures
Name Time Method Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM) 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by incidence of hospital readmissions at 30 and 90 days within a 5-year period 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU) 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by time spent on ventilator in ICU 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by incidence of discharge to a skilled nursing facility (SNF) or long term care (LTC) facility 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by hospitalization length of stay (LOS) 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by primary reason for outpatient office visits within 30 and 90 days within a 5-year period 5 years Assessments of overall healthcare resource outpatient utilization will be summarized
Overall healthcare resource utilization assessed by duration of hospital readmissions at 30 and 90 days within a 5-year period 5 years Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by outpatient utilization 5 years Number of ED visits during the follow-up period
Overall healthcare resource utilization assessed by frequency of outpatient visits within 30 and 90 days within a 5-year period 5 years Assessments of overall healthcare resource outpatient utilization will be summarized
Trial Locations
- Locations (55)
Emory University
🇺🇸Atlanta, Georgia, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Stanford Health Care
🇺🇸Palo Alto, California, United States
David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
University of California
🇺🇸Davis, California, United States
Olive View UCLA Medical Center
🇺🇸Sylmar, California, United States
LA BioMed
🇺🇸Torrance, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Loyola University
🇺🇸Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Washington University St. Louis
🇺🇸Saint Louis, Missouri, United States
Roswell Park Cancer Center
🇺🇸Buffalo, New York, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸Somerville, New Jersey, United States
Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Regional Infectious Disease and Infusion Center, Inc.
🇺🇸Lima, Ohio, United States
Good Samaritan Hospital
🇺🇸Corvallis, Oregon, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
St. Jude Childrens Research Hospital
🇺🇸Memphis, Tennessee, United States
WVU Medicine
🇺🇸Morgantown, West Virginia, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
University of Texas Health Science Center
🇺🇸Houston, Texas, United States
Swedish Health System
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
St. Joseph's Hospital
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Michigan Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States