European Study of Cerebral Aspergillosis Treated With Isavuconazole

NCT04486885 | Completed

• 1 other identifier: hj-20-ESCAI
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Aspergillosis; Invasive Aspergillosis

Keywords

cerebral aspergillosis; isavuconazole

Outcome Measures

Primary Outcomes (1)

• Outcome of the patients : alive without CA treatment/alive under CA treatment/ deceased.

  Number of patients alive without CA treatment/alive under CA treatment/ deceased.

  At baseline

Secondary Outcomes (2)

• Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid

  At baseline

• -Adverse events under isavuconazole and drug interactions

  At baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 adult ou pediatric patients, suffering frome cerebral aspergillosis, diagnosed between 2017 and 2020, and treated by isavuconazole at least 7 days

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imagine Institute: lead

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Study Officials

• Fanny Lanternier, MD

  Hôpital Necker

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

FR (1)