Registry of Patients Treated With Systemic Mold-Active Triazoles

October 18, 2024 updated by: Astellas Pharma Global Development, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2015

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama - Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Davis, California, United States, 95616
        • University of California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine
      • Palo Alto, California, United States, 94305
        • Stanford Health Care
      • Sylmar, California, United States, 91342
        • Olive View UCLA Medical Center
      • Torrance, California, United States, 90502
        • LA BioMed
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
      • Chicago, Illinois, United States, 60660
        • Loyola University
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University St. Louis
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • Somerville, New Jersey, United States, 08876
        • Robert Wood Johnson University Hospital Somerset
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Lima, Ohio, United States, 45801
        • Regional Infectious Disease and Infusion Center, Inc.
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Hospital
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Rhode Island Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Childrens Research Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Health System
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • WVU Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients on a mold-active triazole

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Isavuconazonium sulfate Group
Oral and Intravenous
Drug: Isavuconazonium sulfate
Oral and Intravenous
Other Names:
  • Cresemba
Voriconazole Group
Oral and Intravenous
Drug: Voriconazole
Oral and Intravenous
Other Names:
  • Vfend
Posaconazole Group
Oral and Intravenous
Drug: Posaconazole
Oral and intravenous
Other Names:
  • Noxafil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment patterns of care assessed by reason for therapy
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by category of diagnosis at time of therapy initiation
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by onset of treatment/prophylaxis
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by length of treatment/prophylaxis
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by use of diagnostic method(s)
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by type of diagnostic method(s) used
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by use of therapeutic drug monitoring (TDM)
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by occurrence of drug-drug interactions (DDI)
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by the sequence of invasive fungal infection treatment (IFI)
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Treatment patterns of care assessed by discontinuation due to adverse events (AEs) or other reasons
Time Frame: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
5 years
Patient characteristics assessed by underlying host/risk factors
Time Frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
5 years
Patient characteristics assessed by patient baseline characteristics
Time Frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
5 years
Patient characteristics assessed by fungal disease diagnosis
Time Frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
5 years
Patient characteristics assessed by pathogen treated
Time Frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
5 years
Patient characteristics assessed by pathogen susceptibility
Time Frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
5 years
Patient characteristics assessed by site of fungal infection
Time Frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU)
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by time spent on ventilator in ICU
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by incidence of discharge to a skilled nursing facility (SNF) or long term care (LTC) facility
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by incidence of hospital readmissions at 30 and 90 days within a 5-year period
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by duration of hospital readmissions at 30 and 90 days within a 5-year period
Time Frame: 5 years
Assessments of overall healthcare resource inpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by outpatient utilization
Time Frame: 5 years
Number of ED visits during the follow-up period
5 years
Overall healthcare resource utilization assessed by frequency of outpatient visits within 30 and 90 days within a 5-year period
Time Frame: 5 years
Assessments of overall healthcare resource outpatient utilization will be summarized
5 years
Overall healthcare resource utilization assessed by primary reason for outpatient office visits within 30 and 90 days within a 5-year period
Time Frame: 5 years
Assessments of overall healthcare resource outpatient utilization will be summarized
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Senior Medical Director, Astellas Pharma Global Development, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9766-MA-3034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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