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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03066011
Other study ID # 9766-MA-3034
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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