Registry of Patients Treated With Systemic Mold-Active Triazoles

NCT ID: NCT03066011

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2015 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-16

Study Completion Date

2020-04-24

Brief Summary

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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).

Detailed Description

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Conditions

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Invasive Fungal Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Isavuconazonium sulfate Group

Oral and Intravenous

Isavuconazonium sulfate

Intervention Type DRUG

Oral and Intravenous

Voriconazole Group

Oral and Intravenous

Voriconazole

Intervention Type DRUG

Oral and Intravenous

Posaconazole Group

Oral and Intravenous

Posaconazole

Intervention Type DRUG

Oral and intravenous

Interventions

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Isavuconazonium sulfate

Oral and Intravenous

Intervention Type DRUG

Voriconazole

Oral and Intravenous

Intervention Type DRUG

Posaconazole

Oral and intravenous

Intervention Type DRUG

Other Intervention Names

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Cresemba Vfend Noxafil

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Senior Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

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University of Alabama - Birmingham

Birmingham, Alabama, United States

Site Status

St. Joseph's Hospital

Phoenix, Arizona, United States

Site Status

Mayo Clinic

Phoenix, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

University of California

Davis, California, United States

Site Status

David Geffen School of Medicine

Los Angeles, California, United States

Site Status

Stanford Health Care

Palo Alto, California, United States

Site Status

Olive View UCLA Medical Center

Sylmar, California, United States

Site Status

LA BioMed

Torrance, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Augusta University

Augusta, Georgia, United States

Site Status

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Loyola University

Chicago, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Indiana University Health

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Tulane Medical Center

New Orleans, Louisiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Washington University St. Louis

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Site Status

Roswell Park Cancer Center

Buffalo, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital

New York, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Regional Infectious Disease and Infusion Center, Inc.

Lima, Ohio, United States

Site Status

Good Samaritan Hospital

Corvallis, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

St. Jude Childrens Research Hospital

Memphis, Tennessee, United States

Site Status

University of Texas Health Science Center

Houston, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Swedish Health System

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

WVU Medicine

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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9766-MA-3034

Identifier Type: -

Identifier Source: org_study_id

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