Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT04550936
Study type Observational
Source Pfizer
Status Completed
Start date March 10, 2021
Completion date December 23, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06028451 - ManagemEnt of Antifungal Drug in Invasive Aspergillosis´╝Üa Real-word Study
Completed NCT00163722 - A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients Phase 3
Completed NCT02394483 - Single Ascending Oral Dose Study of F901318 Phase 1
Completed NCT01128907 - Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients N/A
Completed NCT00404092 - Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis Phase 2
Recruiting NCT01386437 - Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Withdrawn NCT02912026 - Radiolabelled IV and Oral Metabolism Study of F901318 Phase 1
Withdrawn NCT03095547 - Drug/Drug Interactions With F901318 Phase 1
Withdrawn NCT03076905 - Pharmacokinetics of IV Formulation Phase 1
Completed NCT02737371 - Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects Phase 1
Terminated NCT00836875 - A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children Phase 3
Active, not recruiting NCT00838643 - Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) N/A
Terminated NCT04876716 - Azole-echinocandin Combination Therapy for Invasive Aspergillosis Phase 3
Recruiting NCT05101187 - Olorofim Aspergillus Infection Study Phase 3
Enrolling by invitation NCT02104479 - Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
Not yet recruiting NCT05707832 - A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus Phase 3
Recruiting NCT06382922 - Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy
Terminated NCT02396225 - Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration N/A
Recruiting NCT00843804 - Surveillance for Nosocomial Infections in Pediatric Cancer Patients N/A
Completed NCT00334412 - COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis Phase 4