European Study of Cerebral Aspergillosis Treated With Isa... | NCT04486885

Studies
European Study of Cerebral Aspergillosis Treated With Isavuconazole

NCT04486885

Sponsor

Imagine Institute

Status

Completed

Last Update Posted

Apr 30, 2025Actual

Enrollment

41Actual

Phase

Not provided

Conditions

Cerebral Aspergillosis
Invasive Aspergillosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Jul 22, 2020

First Submission Date that Met QC Criteria

Jul 22, 2020

First Posted Date

Jul 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2025

Last Update Posted Date

Apr 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
-Adverse events under isavuconazole and drug interactions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fanny Lanternier, MD	Hôpital Necker	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Necker-Enfants Malades		Paris		75015	France