Registry of Patients Treated With Systemic Mold-Active Triazoles

Sponsor

Astellas Pharma Global Development, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03066011

Collaborator

(none)

2,015

Enrollment

Locations

37.3

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infection	Drug: Isavuconazonium sulfate Drug: Voriconazole Drug: Posaconazole

Study Design

Study Type:

Observational

Actual Enrollment :

2015 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 16, 2017

Actual Primary Completion Date :

Apr 24, 2020

Actual Study Completion Date :

Apr 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Treatment patterns of care assessed by reason for therapy [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 [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 [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 [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) [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 [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) [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) [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) [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 [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 [5 years]
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by patient baseline characteristics [5 years]
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by fungal disease diagnosis [5 years]
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by pathogen treated [5 years]
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by pathogen susceptibility [5 years]
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by site of fungal infection [5 years]
The summaries of patient characteristics will be by MAT treatment at baseline and overall.

Secondary Outcome Measures

Overall healthcare resource utilization assessed by hospitalization length of stay (LOS) [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU) [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by time spent on ventilator in ICU [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM) [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by incidence of discharge to a skilled nursing facility (SNF) or long term care (LTC) facility [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by incidence of hospital readmissions at 30 and 90 days within a 5-year period [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by duration of hospital readmissions at 30 and 90 days within a 5-year period [5 years]
Assessments of overall healthcare resource inpatient utilization will be summarized
Overall healthcare resource utilization assessed by outpatient utilization [5 years]
Number of ED visits during the follow-up period
Overall healthcare resource utilization assessed by frequency of outpatient visits within 30 and 90 days within a 5-year period [5 years]
Assessments of overall healthcare resource outpatient utilization will be summarized
Overall healthcare resource utilization assessed by primary reason for outpatient office visits within 30 and 90 days within a 5-year period [5 years]
Assessments of overall healthcare resource outpatient utilization will be summarized

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama - Birmingham	Birmingham	Alabama	United States	35294
2	St. Joseph's Hospital	Phoenix	Arizona	United States	85013
3	Mayo Clinic	Phoenix	Arizona	United States	85054
4	University of Arizona	Tucson	Arizona	United States	85724
5	University of California	Davis	California	United States	95616
6	David Geffen School of Medicine	Los Angeles	California	United States	90095
7	Stanford Health Care	Palo Alto	California	United States	94305
8	Olive View UCLA Medical Center	Sylmar	California	United States	91342
9	LA BioMed	Torrance	California	United States	90502
10	University of Colorado	Aurora	Colorado	United States	80045
11	Yale School of Medicine	New Haven	Connecticut	United States	06520
12	Emory University	Atlanta	Georgia	United States	30322
13	Augusta University	Augusta	Georgia	United States	30912
14	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
15	Northwestern University	Chicago	Illinois	United States	60611
16	University of Illinois at Chicago	Chicago	Illinois	United States	60612
17	University of Chicago	Chicago	Illinois	United States	60637
18	Loyola University	Chicago	Illinois	United States	60660
19	Springfield Clinic	Springfield	Illinois	United States	62703
20	Indiana University Health	Indianapolis	Indiana	United States	46202
21	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
22	University of Kentucky	Lexington	Kentucky	United States	40536
23	Norton Cancer Institute	Louisville	Kentucky	United States	40207
24	Tulane Medical Center	New Orleans	Louisiana	United States	70112
25	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
26	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
27	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
28	University of Michigan Cancer Center	Ann Arbor	Michigan	United States	48109
29	Wayne State University	Detroit	Michigan	United States	48201
30	Henry Ford Hospital	Detroit	Michigan	United States	48202
31	University of Minnesota	Minneapolis	Minnesota	United States	55455
32	Mayo Clinic	Rochester	Minnesota	United States	55905
33	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
34	Washington University St. Louis	Saint Louis	Missouri	United States	63110
35	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
36	Cooper University Hospital	Camden	New Jersey	United States	08103
37	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey	United States	08876
38	Roswell Park Cancer Center	Buffalo	New York	United States	14263
39	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
40	Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital	New York	New York	United States	10065
41	Duke University	Durham	North Carolina	United States	27710
42	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
43	Case Western Reserve University	Cleveland	Ohio	United States	44106
44	Regional Infectious Disease and Infusion Center, Inc.	Lima	Ohio	United States	45801
45	Good Samaritan Hospital	Corvallis	Oregon	United States	97330
46	Oregon Health and Science University	Portland	Oregon	United States	97239
47	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
48	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
49	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
50	Rhode Island Hospital	Providence	Rhode Island	United States	02912
51	St. Jude Childrens Research Hospital	Memphis	Tennessee	United States	38105
52	University of Texas Health Science Center	Houston	Texas	United States	77030
53	Virginia Commonwealth University	Richmond	Virginia	United States	23298
54	Swedish Health System	Seattle	Washington	United States	98104
55	University of Washington Medical Center	Seattle	Washington	United States	98195
56	WVU Medicine	Morgantown	West Virginia	United States	26506