Cerebral AspergillosisESCAINCT04486885
European Study of Cerebral Aspergillosis Treated With Isavuconazole
An observational study of Cerebral Aspergillosis and Invasive Aspergillosis, run by Imagine Institute at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Aspergillosis, Invasive Aspergillosis
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Possible cerebral aspergillosis
- isavuconazole treatment for less than 7 days
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Aspergillosis, Invasive Aspergillosis
- Keywords
- cerebral aspergillosis, isavuconazole
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (2)
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
Measured: At baseline
-Adverse events under isavuconazole and drug interactions
Adverse events under isavuconazole and drug interactions
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Aug 2021
- Primary completion1 Aug 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny Lanternier, MD, Principal investigator, Hôpital Necker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486885
- Sponsor's protocol ID
- hj-20-ESCAI
- Acronym
- ESCAI
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Study of Cerebral Aspergillosis Treated With Isavuconazole
- ClinicalTrials.gov ID
- NCT04486885
- Acronym / sponsor ID
- ESCAI / hj-20-ESCAI
- Conditions
- Cerebral Aspergillosis, Invasive Aspergillosis
- Keywords
- cerebral aspergillosis, isavuconazole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Possible cerebral aspergillosis
- isavuconazole treatment for less than 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid
Time frame: At baseline
-Adverse events under isavuconazole and drug interactions
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny Lanternier, MD principal investigator
Hôpital Necker
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Aspergillosis and Invasive Aspergillosis, run by Imagine Institute at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of the patients : alive without CA treatment/alive under CA treatment/ deceased. (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.