Invasive Fungal InfectionNCT03066011
Registry of Patients Treated With Systemic Mold-Active Triazoles
An observational study of Invasive Fungal Infection, run by Astellas Pharma Global Development, Inc. at 56 sites in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Fungal Infection
- What is being tested?
- Isavuconazonium sulfate, Voriconazole and Posaconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 2,015 participants
- Where
- 56 sitesUnited States
- Study dates
- 16 Mar 2017to 24 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients on a mold-active triazole
Who may be able to join
- Patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (ISAV), voriconazole (VORI), posaconazole (POSA).
Who cannot join
- 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.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30912
University of Colorado
Aurora, Colorado, 80045
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Center
Buffalo, New York, 14263
Cooper University Hospital
Camden, New Jersey, 08103
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Loyola University
Chicago, Illinois, 60660
Case Western Reserve University
Cleveland, Ohio, 44106
Good Samaritan Hospital
Corvallis, Oregon, 97330
University of California
Davis, California, 95616
Wayne State University
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center
Houston, Texas, 77030
Indiana University Health
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Kentucky
Lexington, Kentucky, 40536
Regional Infectious Disease and Infusion Center, Inc.
Lima, Ohio, 45801
David Geffen School of Medicine
Los Angeles, California, 90095
Norton Cancer Institute
Louisville, Kentucky, 40207
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Minnesota
Minneapolis, Minnesota, 55455
WVU Medicine
Morgantown, West Virginia, 26506
Yale School of Medicine
New Haven, Connecticut, 06520
Tulane Medical Center
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital
New York, New York, 10065
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford Health Care
Palo Alto, California, 94305
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Joseph's Hospital
Phoenix, Arizona, 85013
Mayo Clinic
Phoenix, Arizona, 85054
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02912
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Swedish Health System
Seattle, Washington, 98104
University of Washington Medical Center
Seattle, Washington, 98195
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
Springfield Clinic
Springfield, Illinois, 62703
Washington University St. Louis
St Louis, Missouri, 63110
Olive View UCLA Medical Center
Sylmar, California, 91342
LA BioMed
Torrance, California, 90502
University of Arizona
Tucson, Arizona, 85724
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: 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).
- Conditions
- Invasive Fungal Infection
- Being tested
- Isavuconazonium sulfate, Voriconazole, Posaconazole
- Keywords
- mold-active triazoles
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isavuconazonium sulfateDrug
Also called Cresemba
Oral and Intravenous
VoriconazoleDrug
Also called Vfend
Oral and Intravenous
PosaconazoleDrug
Also called Noxafil
Oral and intravenous
| Study group | Role | What they receive |
|---|---|---|
| Isavuconazonium sulfate Group | Oral and Intravenous Receives: Drug: Isavuconazonium sulfate | |
| Voriconazole Group | Oral and Intravenous Receives: Drug: Voriconazole | |
| Posaconazole Group | Oral and Intravenous Receives: Drug: Posaconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Patient characteristics assessed by underlying host/risk factors
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Measured: 5 years
Patient characteristics assessed by patient baseline characteristics
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Measured: 5 years
Patient characteristics assessed by fungal disease diagnosis
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Measured: 5 years
Patient characteristics assessed by pathogen treated
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Measured: 5 years
Patient characteristics assessed by pathogen susceptibility
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Measured: 5 years
Patient characteristics assessed by site of fungal infection
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Measured: 5 years
Secondary outcomes (13)
Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)
Assessments of overall healthcare resource inpatient utilization will be summarized
Measured: 5 years
Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU)
Assessments of overall healthcare resource inpatient utilization will be summarized
Measured: 5 years
Overall healthcare resource utilization assessed by time spent on ventilator in ICU
Assessments of overall healthcare resource inpatient utilization will be summarized
Measured: 5 years
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
Measured: 5 years
Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)
Assessments of overall healthcare resource inpatient utilization will be summarized
Measured: 5 years
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
Measured: 5 years
Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility
Assessments of overall healthcare resource inpatient utilization will be summarized
Measured: 5 years
Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility
Assessments of overall healthcare resource inpatient utilization will be summarized
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Overall healthcare resource utilization assessed by outpatient utilization
Number of ED visits during the follow-up period
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start16 Mar 2017
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066011
- Sponsor's protocol ID
- 9766-MA-3034
- Status last verified
- Aug 2020
- First submitted
- 23 Feb 2017
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles
- ClinicalTrials.gov ID
- NCT03066011
- Acronym / sponsor ID
- 9766-MA-3034
- Conditions
- Invasive Fungal Infection
- Keywords
- mold-active triazoles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,015 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isavuconazonium sulfate Group | – | Drug: Isavuconazonium sulfateOral and Intravenous |
| Voriconazole Group | – | Drug: VoriconazoleOral and Intravenous |
| Posaconazole Group | – | Drug: PosaconazoleOral and Intravenous |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients on a mold-active triazole
Key inclusion criteria (1 listed)
- Patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (ISAV), voriconazole (VORI), posaconazole (POSA).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isavuconazonium sulfateAlso: CresembaOral and Intravenous | Drug | Isavuconazonium sulfate Group |
| VoriconazoleAlso: VfendOral and Intravenous | Drug | Voriconazole Group |
| PosaconazoleAlso: NoxafilOral and intravenous | Drug | Posaconazole Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Patient characteristics assessed by pathogen treated
Time frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by pathogen susceptibility
Time frame: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
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.
13 secondary outcomes
Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)
Time frame: 5 years
Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU)
Time frame: 5 years
Overall healthcare resource utilization assessed by time spent on ventilator in ICU
Time frame: 5 years
Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation
Time frame: 5 years
Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)
Time frame: 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
Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility
Time frame: 5 years
Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility
Time frame: 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
Overall healthcare resource utilization assessed by duration of hospital readmissions at 30 and 90 days within a 5-year period
Time frame: 5 years
Overall healthcare resource utilization assessed by outpatient utilization
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infection, run by Astellas Pharma Global Development, Inc. at 56 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment patterns of care assessed by reason for therapy (time frame: 5 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.