Registry of Patients Treated With Systemic Mold-Active Triazoles
Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles
1 other identifier
observational
2,015
1 country
56
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedStudy Start
First participant enrolled
March 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2020
CompletedOctober 21, 2024
August 1, 2020
3.1 years
February 23, 2017
October 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
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 Outcomes (13)
Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)
5 years
Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU)
5 years
Overall healthcare resource utilization assessed by time spent on ventilator in ICU
5 years
Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation
5 years
Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)
5 years
- +8 more secondary outcomes
Study Arms (3)
Isavuconazonium sulfate Group
Oral and Intravenous
Voriconazole Group
Oral and Intravenous
Posaconazole Group
Oral and Intravenous
Interventions
Eligibility Criteria
Patients on a mold-active triazole
You may qualify if:
- Patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (ISAV), voriconazole (VORI), posaconazole (POSA).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
University of Alabama - Birmingham
Birmingham, Alabama, 35294, United States
St. Joseph's Hospital
Phoenix, Arizona, 85013, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of Arizona
Tucson, Arizona, 85724, United States
University of California
Davis, California, 95616, United States
David Geffen School of Medicine
Los Angeles, California, 90095, United States
Stanford Health Care
Palo Alto, California, 94305, United States
Olive View UCLA Medical Center
Sylmar, California, 91342, United States
LA BioMed
Torrance, California, 90502, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Emory University
Atlanta, Georgia, 30322, United States
Augusta University
Augusta, Georgia, 30912, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University
Chicago, Illinois, 60660, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University St. Louis
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Roswell Park Cancer Center
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Regional Infectious Disease and Infusion Center, Inc.
Lima, Ohio, 45801, United States
Good Samaritan Hospital
Corvallis, Oregon, 97330, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Rhode Island Hospital
Providence, Rhode Island, 02912, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105, United States
University of Texas Health Science Center
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Swedish Health System
Seattle, Washington, 98104, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
WVU Medicine
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2017
First Posted
February 28, 2017
Study Start
March 16, 2017
Primary Completion
April 24, 2020
Study Completion
April 24, 2020
Last Updated
October 21, 2024
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.