Clinical trial NCT03066011: Registry of Patients Treated With Systemic Mold-Active Triazoles
Official title: Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infection
Keywords: mold-active triazoles
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-02-28
Enrollment: 2015
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients on a mold-active triazole

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment patterns of care assessed by reason for therapy
timeFrame: 5 years
measure: Treatment patterns of care assessed by category of diagnosis at time of therapy initiation
timeFrame: 5 years
measure: Treatment patterns of care assessed by onset of treatment/prophylaxis
timeFrame: 5 years
measure: Treatment patterns of care assessed by length of treatment/prophylaxis
timeFrame: 5 years
measure: Treatment patterns of care assessed by use of diagnostic method(s)
timeFrame: 5 years
measure: Treatment patterns of care assessed by type of diagnostic method(s) used
timeFrame: 5 years
measure: Treatment patterns of care assessed by use of therapeutic drug monitoring (TDM)
timeFrame: 5 years
measure: Treatment patterns of care assessed by occurrence of drug-drug interactions (DDI)
timeFrame: 5 years
measure: Treatment patterns of care assessed by the sequence of invasive fungal infection treatment (IFI)
timeFrame: 5 years
measure: Treatment patterns of care assessed by discontinuation due to adverse events (AEs) or other reasons
timeFrame: 5 years
measure: Patient characteristics assessed by underlying host/risk factors
timeFrame: 5 years
measure: Patient characteristics assessed by patient baseline characteristics
timeFrame: 5 years
measure: Patient characteristics assessed by fungal disease diagnosis
timeFrame: 5 years
measure: Patient characteristics assessed by pathogen treated
timeFrame: 5 years
measure: Patient characteristics assessed by pathogen susceptibility
timeFrame: 5 years
measure: Patient characteristics assessed by site of fungal infection
timeFrame: 5 years
Secondary outcomes:
measure: Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU)
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by time spent on ventilator in ICU
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by incidence of discharge to a skilled nursing facility (SNF) or long term care (LTC) facility
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by incidence of hospital readmissions at 30 and 90 days within a 5-year period
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by duration of hospital readmissions at 30 and 90 days within a 5-year period
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by outpatient utilization
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by frequency of outpatient visits within 30 and 90 days within a 5-year period
timeFrame: 5 years
measure: Overall healthcare resource utilization assessed by primary reason for outpatient office visits within 30 and 90 days within a 5-year period
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Davis
country: United States
facility: University of California
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine
state: California
city: Palo Alto
country: United States
facility: Stanford Health Care
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center
state: California
city: Torrance
country: United States
facility: LA BioMed
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Loyola University
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University St. Louis
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Somerville
country: United States
facility: Robert Wood Johnson University Hospital Somerset
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Lima
country: United States
facility: Regional Infectious Disease and Infusion Center, Inc.
state: Ohio
city: Corvallis
country: United States
facility: Good Samaritan Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Swedish Health System
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Morgantown
country: United States
facility: WVU Medicine
state: West Virginia
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Senior Medical Director
role: STUDY_DIRECTOR
References: