A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions. (PRISMA)

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)

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.

Study Overview

• Status: Completed
• Conditions: Mucormycosis; Invasive Aspergillosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 307

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU de Limoges
  • Paris, France, 75015
    • Paris University
  • Strasbourg, France, 67033
    • Institut de Cancérologie
• Germany
  • Cologne, Germany, 50937
    • University Hospital of Cologne
  • Frankfurt, Germany, 60590
    • Universitätsklinik Frankfurt
  • Munich, Germany, 81675
    • Klinikum rechts der Isar Technische Universität München
  • Ulm, Germany, 89081
    • Comprehensive Cancer Center Ulm (CCCU)
• Italy
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron University Hospital
  • Barcelona, Spain, 08036
    • Fundació Clínic Per A La Recerca Biomèdica
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Santander, Spain, 39011
    • Hospital Universitario Marques de Valdecilla
  • Zaragoza, Spain, 50009
    • University Hospital Miguel Servet
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Neofytos D, Pagliuca A, Houghton K, Broughton E, de Figueiredo Valente MLN, Jiang L, Enoch DA, Gruener B, Herbrecht R, Lahmer T, Lortholary O, Melenotte C, De Rosa FG, Garcia-Vidal C, Jimenez M, Fernandez M, Cornely O. Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019). Infect Dis Ther. 2024 Dec;13(12):2527-2543. doi: 10.1007/s40121-024-01064-4. Epub 2024 Oct 24.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): December 23, 2023
• Study Completion (Actual): December 23, 2023

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Zygomycosis; Mucormycosis; Anti-Infective Agents; Antifungal Agents; isavuconazole
• Other Study ID Numbers: C3791008; NCT04550936 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.