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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 : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 9, 2020
First Posted Date September 16, 2020
Last Update Posted Date September 16, 2020
Estimated Study Start Date October 15, 2020
Estimated Primary Completion Date May 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2020)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 9, 2020)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Invasive Aspergillosis
  • Mucormycosis
Intervention Drug: Isavuconazole
antifungal agent
Other Name: Cresemba
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 9, 2020)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 26, 2022
Estimated Primary Completion Date May 26, 2022   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04550936
Other Study ID Numbers C3791008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2020