This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Eligible patients are adults who have been treated with isavuconazole in routine practice at participating sites since 15 October, 2015 or since the date of launch in the country if it is after 15 October, 2015 until 30 June, 2019. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.
This observational study will include approximately 600 patients diagnosed with invasive aspergillosis or mucormycosis who received treatment with at least one dose of isavuconazole in the hospital setting. Patients will be recruited in approximately 20 sites across 5 countries in Europe. Patients will be followed from isavuconazole initiation (index event) until six-months post-index treatment discontinuation, death, loss to follow-up, or 31 December, 2019, whichever occurs first. De-identified data on patient demographics, disease characteristics, treatment effectiveness, safety outcomes, isavuconazole treatment patterns, and HCRU will be collected from patient medical records and entered into an electronic data capture (EDC) system by site staff. Follow-up data will include details of treatment over time and clinical, radiological, mycological, and healthcare resource utilization outcomes. As this study is retrospective, information pertaining to patient care will already be documented in patient medical records at the time of chart abstraction.
Study Type
OBSERVATIONAL
Enrollment
307
antifungal agent
CHU de Limoges
Limoges, France
Paris University
Paris, France
Institut de Cancérologie
Strasbourg, France
University Hospital of Cologne
Cologne, Germany
Universitätsklinik Frankfurt
Frankfurt, Germany
Klinikum rechts der Isar Technische Universität München
Munich, Germany
Comprehensive Cancer Center Ulm (CCCU)
Ulm, Germany
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Vall d'Hebron University Hospital
Barcelona, Spain
Fundació Clínic Per A La Recerca Biomèdica
Barcelona, Spain
...and 5 more locations
Number of Participants With Clinical Response at Week 6
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Clinical Response at Week 12
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Clinical Response at Week 24
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Radiological Response at Week 6
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: greater than or equal to (\>=) 50 percent (%) improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 6 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Radiological Response at Week 12
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 12 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Radiological Response at Week 24
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 24 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Mycological Response at Week 6
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Mycological Response at Week 12
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Mycological Response at Week 24
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
All-Cause Mortality at Week 6
Number of participants who died due to any cause at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
All-Cause Mortality at Week 12
Number of participants who died due to any cause at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
All-Cause Mortality at Week 24
Number of participants who died due to any cause at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Adverse Event at Week 6
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Adverse Event at Week 12
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Adverse Event at Week 24
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Serious Adverse Event at Week 6
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Serious Adverse Event at Week 12
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Serious Adverse Event at Week 24
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants According to Method of Administration
Number of participants according to method of drug administration: infusion, oral and unknown were reported in this outcome measure.
Time frame: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Number of Participants According to Dosage of Isavuconazole Administration
Number of participants according to dosage of drug administration: 200 milligram (mg), other and unknown were reported in this outcome measure.
Time frame: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Number of Participants With Therapeutic Drug Monitoring (TDM)
Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Isavuconazole Treatment Modification
Treatment modification was defined as change in dose or dosing schedule of participants who received isavuconazole. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Types of Isavuconazole Treatment Modification
Number of participants with type of treatment modifications required during the index period were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
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Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment and Treatment Modification
Duration between Isavuconazole treatment and treatment modification was defined as the date of first modification minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Percentage of Participants Who Discontinued Isavuconazole Treatment
Percentage of participants who discontinued Isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration of Isavuconazole Treatment
Duration between Isavuconazole treatment was defined as the date of discontinuation minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Number of participants with reasons for Isavuconazole treatment discontinuation were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants Who Switched to New Antifungal
Number of participants who switched to new antifungal therapy after discontinuation of Isavuconazole were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Type of New Antifungal Therapy
Number of participants according to new antifungal therapy after end of isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Isavuconazole Administered as Part of Combination Therapy
Number of participants with index treatment administered as part of antifungal combination therapy were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. one participant could have received more than one treatment
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants Who Received Other Concomitant Treatments
Concomitant treatments included: Antibiotic agent, corticosteroid agent, chemotherapy, immunosuppressant agent, other and unknown were reported in this outcome measure. One participant could have more than one treatment. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Any Outpatient Visits
Number of participants with any outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Total Number of Outpatient Visits
Total number of outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Type of Outpatient Visits
Type of outpatient visit (Health Care Professional Visit or Referral) such as secondary care visit (specialist), secondary care referral (specialist), primary care visit (general practitioner) and emergency room (ER) visit were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit
Duration between Isavuconazole treatment was defined as the date of first outpatient visit minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Inpatient Hospitalization
Number of participants according to index treatment administered in the inpatient setting were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants With Primary Reason For Inpatient Hospitalization
Number of participants with primary reason for inpatient hospitalization such as other disease monitoring, other, invasive aspergillosis or mucormycosis disease monitoring, AE related to invasive aspergillosis or mucormycosis and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization
Duration between Isavuconazole treatment was defined as the date of inpatient hospitalization minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Mean Length of Stay For Inpatient Hospitalization
Length of stay was computed as the date of discharge from hospital minus the date of hospitalization plus (+) 1. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Number of Participants According to Location for Inpatient Hospitalization
Number of participants according to location for inpatient hospitalization such as: hematology ward, other ward, intensive care unit, transplantation ward, emergency room, general medicine ward, oncology ward and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)