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Patterns of Real-World Isavuconazole Use - a Study of Patients With Mucormycosis or Invasive Aspergillosis (PRISMA)

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ClinicalTrials.gov Identifier: NCT04550936
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Invasive Aspergillosis Mucormycosis Drug: Isavuconazole

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.

Study Design
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Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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)
Actual Study Start Date : March 10, 2021
Actual Primary Completion Date : December 23, 2023
Actual Study Completion Date : December 23, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Groups and Cohorts
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Intervention Details:
  • Drug: Isavuconazole
    antifungal agent
    Other Name: Cresemba

Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients and their respective clinical outcomes of treatment with isavuconazole [ Time Frame: up to 6 months post-index ]
    overall response, including clinical response, mycological response, radiological response, and mortality

  2. Proportion of patients and their respective safety outcomes of treatment with isavuconazole [ Time Frame: up to 6 months post-index ]
    treatment related AEs and SAEs


Secondary Outcome Measures :
  1. Proportion of patients for each indication and usage pattern of isavuconazole [ Time Frame: up to 6 months post-index ]
    formulation, dosage (loading and maintenance), duration, treatment changes (including dosage adjustments, switching, and discontinuation), and concomitant medication

  2. Proportion of patients and their respective healthcare resource utilization after treatment with isavuconazole [ Time Frame: up to 6 months post-index ]
    length of stay [LOS], emergency room [ER] visits, intensive care unit [ICU] visits and LOS, inpatient hospitalizations, and planned and unplanned outpatient visits


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Contacts and Locations
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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): NCT04550936


Locations
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France
Hôpital Huriez CHU de Lille
Lille, France, 59000
CHU de Limoges
Limoges, France, 87042
Paris University
Paris, France, 75015
Institut de Cancérologie
Strasbourg, France, 67033
Germany
University Hospital of Cologne
Cologne, Germany, 50937
Universitätsklinik Frankfurt
Frankfurt, Germany, 60590
Klinikum rechts der Isar Technische Universität München
Munich, Germany, 81675
Comprehensive Cancer Center Ulm (CCCU)
Ulm, Germany, 89081
Italy
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Fundació Clínic Per A La Recerca Biomèdica
Barcelona, Spain, 08036
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39011
University Hospital Miguel Servet
Zaragoza, Spain, 50009
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
King'S College Hospital Nhs Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04550936    
Other Study ID Numbers: C3791008
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Additional relevant MeSH terms:
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Aspergillosis
Mucormycosis
Zygomycosis
Mycoses
Bacterial Infections and Mycoses
 Infections
Isavuconazole
Antifungal Agents
Anti-Infective Agents