European Study of Cerebral Aspergillosis Treated With Isavuconazole

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.

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Key information

Conditions

Cerebral Aspergillosis Invasive Aspergillosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: At baseline

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

Secondary outcomes

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

Time frame: At baseline

dosage of isavuconazole in the serum and in the cerebro-spinal-fluid
-Adverse events under isavuconazole and drug interactions

Time frame: At baseline

Adverse events under isavuconazole and drug interactions

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Registry information

Acronym: ESCAI

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Jul 27, 2020
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed