Registry of Patients Treated With Systemic Mold-Active Triazoles

Invasive Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066011
• Other study ID #: 9766-MA-3034
• Status: Completed
• Start date: March 16, 2017
• Est. completion date: April 24, 2020

Study information

• Verified date: August 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2015
• Est. completion date: April 24, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Fungal Infection
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Isavuconazonium sulfate
Oral and Intravenous
• Voriconazole
Oral and Intravenous
• Posaconazole
Oral and intravenous

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Center	Buffalo	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Loyola University	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Good Samaritan Hospital	Corvallis	Oregon
United States	University of California	Davis	California
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	University of Texas Health Science Center	Houston	Texas
United States	Indiana University Health	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kentucky	Lexington	Kentucky
United States	Regional Infectious Disease and Infusion Center, Inc.	Lima	Ohio
United States	David Geffen School of Medicine	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	St. Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Minnesota	Minneapolis	Minnesota
United States	WVU Medicine	Morgantown	West Virginia
United States	Yale School of Medicine	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford Health Care	Palo Alto	California
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	St. Joseph's Hospital	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University St. Louis	Saint Louis	Missouri
United States	Swedish Health System	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey
United States	Springfield Clinic	Springfield	Illinois
United States	Olive View UCLA Medical Center	Sylmar	California
United States	LA BioMed	Torrance	California
United States	University of Arizona	Tucson	Arizona
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Patient characteristics assessed by underlying host/risk factors	The summaries of patient characteristics will be by MAT treatment at baseline and overall.	5 years
Primary	Patient characteristics assessed by patient baseline characteristics	The summaries of patient characteristics will be by MAT treatment at baseline and overall.	5 years
Primary	Patient characteristics assessed by fungal disease diagnosis	The summaries of patient characteristics will be by MAT treatment at baseline and overall.	5 years
Primary	Patient characteristics assessed by pathogen treated	The summaries of patient characteristics will be by MAT treatment at baseline and overall.	5 years
Primary	Patient characteristics assessed by pathogen susceptibility	The summaries of patient characteristics will be by MAT treatment at baseline and overall.	5 years
Primary	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	Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)	Assessments of overall healthcare resource inpatient utilization will be summarized	5 years
Secondary	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
Secondary	Overall healthcare resource utilization assessed by time spent on ventilator in ICU	Assessments of overall healthcare resource inpatient utilization will be summarized	5 years
Secondary	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
Secondary	Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)	Assessments of overall healthcare resource inpatient utilization will be summarized	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall healthcare resource utilization assessed by outpatient utilization	Number of ED visits during the follow-up period	5 years
Secondary	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
Secondary	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