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

NCT04550936 | Completed Results

• 2 other identifiers: C3791008NCT04550936
• Study Type: observational
• Target: 307
• Locations: 5 countries
• Sites: 15

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.

Conditions

Mucormycosis; Invasive Aspergillosis

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (22)

• Number of Participants According to Method of Administration

  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

  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)

  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

  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

  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)

Interventions

Isavuconazole DRUG

antifungal agent

Also known as: Cresemba

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation
• 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 )
• Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

CHU de Limoges

Limoges, 87042, France

Location

Paris University

Paris, 75015, France

Location

Institut de Cancérologie

Strasbourg, 67033, France

Location

University Hospital of Cologne

Cologne, 50937, Germany

Location

Universitätsklinik Frankfurt

Frankfurt, 60590, Germany

Location

Klinikum rechts der Isar Technische Universität München

Munich, 81675, Germany

Location

Comprehensive Cancer Center Ulm (CCCU)

Ulm, 89081, Germany

Location

Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Fundació Clínic Per A La Recerca Biomèdica

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39011, Spain

Location

University Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

King'S College Hospital Nhs Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39443403 DERIVED

Related Links

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

MeSH Terms

Conditions

Mucormycosis

Interventions

isavuconazole

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: March 10, 2021
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (5); GB (2); DE (4); FR (3)