Registry of Patients Treated With Systemic Mold-Active Triazoles

Browse trials for

• Mycoses 539
• Invasive Fungal Infections 146

Keywords

• mold-active triazoles

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 2,015 is above the median of 152 across 150 observational studies indexed under Mycoses.

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.

Study population

Groups and cohorts

• Isavuconazonium sulfate Group

  Oral and Intravenous

  Drug: Isavuconazonium sulfate

• Voriconazole Group

  Oral and Intravenous

  Drug: Voriconazole

• Posaconazole Group

  Oral and Intravenous

  Drug: Posaconazole

Interventions

• DrugIsavuconazonium sulfate

  Oral and Intravenous

  Also known as: Cresemba

• DrugVoriconazole

  Oral and Intravenous

  Also known as: Vfend

• DrugPosaconazole

  Oral and intravenous

  Also known as: Noxafil

Primary outcomes

1. 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.

   Time frame: 5 years

2. 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.

   Time frame: 5 years

3. 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.

   Time frame: 5 years

4. 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.

   Time frame: 5 years

5. 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.

   Time frame: 5 years

6. 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.

   Time frame: 5 years

7. 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.

   Time frame: 5 years

8. 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.

   Time frame: 5 years

9. 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.

   Time frame: 5 years

10. 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.

    Time frame: 5 years

11. Patient characteristics assessed by underlying host/risk factors

    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

    Time frame: 5 years

12. Patient characteristics assessed by patient baseline characteristics

    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

    Time frame: 5 years

13. Patient characteristics assessed by fungal disease diagnosis

    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

    Time frame: 5 years

14. Patient characteristics assessed by pathogen treated

    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

    Time frame: 5 years

15. Patient characteristics assessed by pathogen susceptibility

    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

    Time frame: 5 years

16. Patient characteristics assessed by site of fungal infection

    The summaries of patient characteristics will be by MAT treatment at baseline and overall.

    Time frame: 5 years

Secondary outcomes

1. Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)

   Assessments of overall healthcare resource inpatient utilization will be summarized

   Time frame: 5 years

2. Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU)

   Assessments of overall healthcare resource inpatient utilization will be summarized

   Time frame: 5 years

3. Overall healthcare resource utilization assessed by time spent on ventilator in ICU

   Assessments of overall healthcare resource inpatient utilization will be summarized

   Time frame: 5 years

4. 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

   Time frame: 5 years

5. Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)

   Assessments of overall healthcare resource inpatient utilization will be summarized

   Time frame: 5 years

6. 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

   Time frame: 5 years

7. Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility

   Assessments of overall healthcare resource inpatient utilization will be summarized

   Time frame: 5 years

8. Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility

   Assessments of overall healthcare resource inpatient utilization will be summarized

   Time frame: 5 years

9. 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

   Time frame: 5 years

10. 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

    Time frame: 5 years

11. Overall healthcare resource utilization assessed by outpatient utilization

    Number of ED visits during the follow-up period

    Time frame: 5 years

12. 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

    Time frame: 5 years

13. 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

    Time frame: 5 years

Individual participant data

Plan to share: 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/.