Invasive Fungal Infection Clinical Trial
Official title:
Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles
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 |
Verified date | August 2020 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Global Development, Inc. |
United States,
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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