Clinical trial NCT04550936: Patterns of Real-World Isavuconazole Use - a Study of Patients With Mucormycosis or Invasive Aspergillosis
Official title: Patterns of Real-World Isavuconazole Use, Effectiveness, Safety, and Healthcare Resource Utilization-a Retrospective Chart Review Study of Patients With Mucormycosis or Invasive Aspergillosis (PRISMA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Aspergillosis
Mucormycosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who received isavuconazole for the treatment of invasive aspergillosis or mucormycosis in the hospital setting in five European countries (France, Germany, Italy, Spain, and the United Kingdom).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation
2. Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed )
3. Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)

Exclusion Criteria:

1. Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period

Primary outcomes:
measure: Proportion of patients and their respective clinical outcomes of treatment with isavuconazole
timeFrame: up to 6 months post-index
measure: Proportion of patients and their respective safety outcomes of treatment with isavuconazole
timeFrame: up to 6 months post-index
Secondary outcomes:
measure: Proportion of patients for each indication and usage pattern of isavuconazole
timeFrame: up to 6 months post-index
measure: Proportion of patients and their respective healthcare resource utilization after treatment with isavuconazole
timeFrame: up to 6 months post-index
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Huriez CHU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Paris
country: France
facility: Paris University
city: Strasbourg
country: France
facility: Institut de Cancérologie
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Frankfurt
country: Germany
facility: Universitätsklinik Frankfurt
city: Munich
country: Germany
facility: Klinikum rechts der Isar Technische Universität München
city: Ulm
country: Germany
facility: Comprehensive Cancer Center Ulm (CCCU)
city: Turin
country: Italy
facility: Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
state: Piedmont
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Barcelona
country: Spain
facility: Fundació Clínic Per A La Recerca Biomèdica
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Zaragoza
country: Spain
facility: University Hospital Miguel Servet
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: King'S College Hospital Nhs Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: