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

NCT ID: NCT04550936

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 307 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2023-12-23

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.

Conditions

Invasive Aspergillosis; Mucormycosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Isavuconazole

antifungal agent

Intervention Type: DRUG

Other Intervention Names

Cresemba

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

CHU de Limoges

Limoges, , France

Paris University

Paris, , France

Institut de Cancérologie

Strasbourg, , France

University Hospital of Cologne

Cologne, , Germany

Universitätsklinik Frankfurt

Frankfurt, , Germany

Klinikum rechts der Isar Technische Universität München

Munich, , Germany

Comprehensive Cancer Center Ulm (CCCU)

Ulm, , Germany

Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Vall d'Hebron University Hospital

Barcelona, , Spain

Fundació Clínic Per A La Recerca Biomèdica

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

University Hospital Miguel Servet

Zaragoza, , Spain

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

King'S College Hospital Nhs Foundation Trust

London, , United Kingdom

Countries

France; Germany; Italy; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39443403 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3791008

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

Other Identifiers

NCT04550936

Identifier Type: REGISTRY

Identifier Source: secondary_id

C3791008

Identifier Type: -

Identifier Source: org_study_id