Clincosm LogoSign in Get a demo

ESCAI: European Study of Cerebral Aspergillosis Treated With Isavuconazole

Sponsor
Imagine Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04486885
Collaborator
(none)
40
Enrollment
1
Location
19
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    European Study of Cerebral Aspergillosis Treated With Isavuconazole
    Actual Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Outcome of the patients : alive without CA treatment/alive under CA treatment/ deceased. [At baseline]

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

    Secondary Outcome Measures

    1. Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid [At baseline]

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

    2. -Adverse events under isavuconazole and drug interactions [At baseline]

      Adverse events under isavuconazole and drug interactions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Necker-Enfants Malades Paris France 75015

    Sponsors and Collaborators

    • Imagine Institute

    Investigators

    • Principal Investigator: Fanny Lanternier, MD, Hôpital Necker

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imagine Institute
    ClinicalTrials.gov Identifier:
    NCT04486885
    Other Study ID Numbers:
    • hj-20-ESCAI
    First Posted:
    Jul 27, 2020
    Last Update Posted:
    Sep 13, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Imagine Institute
    cerebral aspergillosis
    isavuconazole
    Additional relevant MeSH terms:
    Aspergillosis

    Study Results

    No Results Posted as of Sep 13, 2021