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Completed

NCT Number: NCT03066011

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).

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Key information

Conditions

Invasive Fungal Infection Bacterial Infections and Mycoses Infections Invasive Fungal Infections Mycoses

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isavuconazonium sulfate

Drug

Oral and Intravenous

Other names: Cresemba

Voriconazole

Drug

Oral and Intravenous

Other names: Vfend

Posaconazole

Drug

Oral and intravenous

Other names: Noxafil

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2017
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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