European Study of Cerebral Aspergillosis Treated With Isavuconazole (ESCAI)

September 6, 2021 updated by: Imagine Institute

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Hopital Necker-Enfants Malades
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline
-Adverse events under isavuconazole and drug interactions
Time Frame: At baseline
Adverse events under isavuconazole and drug interactions
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imagine Institute

Investigators

  • Principal Investigator: Fanny Lanternier, MD, Hôpital Necker

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hj-20-ESCAI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Aspergillosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe