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Registry of Patients Treated With Systemic Mold-Active Triazoles

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ClinicalTrials.gov Identifier: NCT03066011
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

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
Invasive Fungal Infection Drug: Isavuconazonium sulfate Drug: Voriconazole Drug: Posaconazole

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Isavuconazonium sulfate Group
Oral and Intravenous
Drug: Isavuconazonium sulfate
Oral and Intravenous
Other Name: Cresemba

Voriconazole Group
Oral and Intravenous
Drug: Voriconazole
Oral and Intravenous
Other Name: Vfend

Posaconazole Group
Oral and Intravenous
Drug: Posaconazole
Oral and intravenous
Other Name: Noxafil




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Patient characteristics assessed by pathogen treated [ Time Frame: 5 years ]
    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

  15. Patient characteristics assessed by pathogen susceptibility [ Time Frame: 5 years ]
    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

  16. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Overall healthcare resource utilization assessed by outpatient utilization [ Time Frame: 5 years ]
    Number of ED visits during the follow-up period

  12. 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

  13. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients on a mold-active triazole
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066011


Contacts
Contact: Astellas Pharma Global Development 800-888-7704 astellas.registration@astellas.com

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Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03066011     History of Changes
Other Study ID Numbers: 9766-MA-3034
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
mold-active triazoles

Additional relevant MeSH terms:
Mycoses
Invasive Fungal Infections
Voriconazole
Posaconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents