European Study of Cerebral Aspergillosis Treated With Isavuconazole

Invasive Aspergillosis Clinical Trial

— ESCAI  

Official title:

European Study of Cerebral Aspergillosis Treated With Isavuconazole

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486885
• Other study ID #: hj-20-ESCAI
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: September 2021
• Source: Imagine Institute
• Contact: Fanny Lanternier, MD
• Phone: 01 44 49 52 62
• Email: fanny.lanternier[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Cerebral Aspergillosis
• Invasive Aspergillosis

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid	dosage of isavuconazole in the serum and in the cerebro-spinal-fluid	At baseline
Secondary	-Adverse events under isavuconazole and drug interactions	Adverse events under isavuconazole and drug interactions	At baseline