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

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04550936
Collaborator
(none)
600
1
14.5
41.3

Study Details

Study Description

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 Phase

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

Study Type:
Observational
Anticipated Enrollment :
600 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 :
Mar 10, 2021
Anticipated Primary Completion Date :
May 26, 2022
Anticipated Study Completion Date :
May 26, 2022

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients and their respective clinical outcomes of treatment with isavuconazole [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Fundació Clínic Per A La Recerca Biomèdica Barcelona Spain 08036

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04550936
Other Study ID Numbers:
  • C3791008
First Posted:
Sep 16, 2020
Last Update Posted:
Jun 15, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2021