European Study of Cerebral Aspergillosis Treated With Isavuconazole

Completed

• Conditions: Cerebral Aspergillosis; Invasive Aspergillosis

• Registration Number: NCT04486885
• Lead Sponsor: Imagine Institute

Brief Summary

Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole is the recommended first line treatment of invasive aspergillosis. More recently, isavuconazole appeared to be not less effective than voriconazole in the treatment of filamentous IFI, with a better tolerance profile.

The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the treatment of cerebral aspergillosis by a descriptive, multicentric, international retrospective cohort study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2021-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2023-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Proven or probable cerebral aspergillosis according to the EORTC criteria modified by adding diabetes in the host criteria
• In child or adult
• Treated by isavuconazole at least 7 days
• Diagnosed between March 2017 and June 2020

Exclusion Criteria

• Possible cerebral aspergillosis
• isavuconazole treatment for less than 7 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome of the patients : alive without CA treatment/alive under CA treatment/ deceased.	At baseline	Number of patients alive without CA treatment/alive under CA treatment/ deceased.

Secondary Outcome Measures

Name	Time	Method
Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid	At baseline	dosage of isavuconazole in the serum and in the cerebro-spinal-fluid
-Adverse events under isavuconazole and drug interactions	At baseline	Adverse events under isavuconazole and drug interactions

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France