MucormycosisZygoRéaNCT03387696
Mucormycosis in ICU
An observational study of Mucormycosis, run by University Hospital, Grenoble at 21 sites in France.
Trial summary
Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucormycosis
- How many people
- 74 participants
- Where
- 21 sitesFrance
- Study dates
- 8 Sep 2017to 1 Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with mycormycosis hospitalized in intensive care unit during the 2008-2016 period
Who may be able to join
- confirmed or suspected mucormycosis, based on international definition from EORTC/MSG
- patient hospitalized in intensive care unit during the 2008-2016 period
- Zygomycosis identification in at least 2 solids organs or identification in hemoculture
Who cannot join
- Age under 18 years old
- Patient under the law
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Intensive Care Unit - Hospital Amiens
Amiens
Intensive Care Unit - Hospital Angers
Angers
Intensive Care Unit - Hospital Besançon
Besançon
Intensive Care Unit - Hospital Béthune
Béthune
Intensive Care Unit - Hospital Caen
Caen
Intensive Care Unit - Hospital Clermont-Ferrand
Clermont-Ferrand
Intensive Care Unit - Hospital Dijon
Dijon
Intensive Care Unit - Hospital Grenoble Alpes
Grenoble
Intensive Care Unit - Hospital Lille
Lille
Intensive Care Unit - Hospital Lyon
Lyon
Intensive Care Unit - Hospital Montpellier
Montpellier
Intensive Care Unit - Hospital Nantes
Nantes
Intensive Care Unit - Hospital l'Archet - Nice
Nice
Intensive Care Unit - Hospital Bichat
Paris
Intensive Care Unit - Hospital Saint Louis
Paris
Intensive Care Unit - Hospital Tenon
Paris
Intensive Care Unit - Hospital Poitiers
Poitiers
Intensive Care Unit - Hospital Rennes
Rennes
Intensive Care Unit - Hospital Rouen
Rouen
Intensive Care Unit - Hospital Saint Etienne
Saint-Etienne
Intensive Care Unit - Hospital Tours
Tours
About this study
Official title: Mucormycosis in ICU: A French Multicenter Cohort Study
Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns.
ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU.
Read the detailed description
Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns. The incidence of Mucormycosis is currently increasing reaching 7% of invasive fungal infections in some immunocompromised patients. Because of its aggressive nature, Mucormycosis is associated with poor survival and high morbidity ; mortality is estimated between 16% and 64% according to different retrospective studies. No study has ever evaluated prognosis of patients with mucormycosis admitted in intensive care units (ICU).
ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU and to evaluate the prognosis of different subgroups of patients according to :
- their clinical characteristics : demographic characteristics, clinical conditions and factors of immunosuppression
- the characteristics of the fungal infection
- the treatment strategy
- the severity of the initial illness, evaluated by severity scores
Twenty-one French ICU are currently including more than 45 patients.
- Conditions
- Mucormycosis
- Keywords
- Mucormycosis, Intensive Care Medicine
- Medical subject headings
- Mucormycosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at Day 28
Mortality at Day 28 after ICU admission
Measured: up to 28 days
Secondary outcomes (6)
Mortality at Day 90
Mortality at Day 90 after ICU admission
Measured: up to 90 days
Mortality during the ICU stage
Mortality status (alive or dead) at the end of the ICU stage
Measured: up to 28 days
Length stay in ICU
number of days in intensive care Unit
Measured: up to 28 days
Length stay of hospitalization
number of days in hospital
Measured: up to 90 days
Mortality during the hospitalization
Mortality status (alive or dead) at the end of the hospitalization
Measured: up to 90 days
Prognostic criteria
Prognostic factors of mortality in intensive care units
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start8 Sep 2017
- Primary completion10 Sep 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucormycosisStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387696
- Sponsor's protocol ID
- ZygoRea (38RC17.008)
- Acronym
- ZygoRéa
- Status last verified
- Nov 2022
- First submitted
- 1 Dec 2017
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucormycosis in ICU: A French Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03387696
- Acronym / sponsor ID
- ZygoRéa / ZygoRea (38RC17.008)
- Conditions
- Mucormycosis
- Keywords
- Mucormycosis, Intensive Care Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 2 Jan 2018 (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.
Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns.
ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU.
Detailed description
Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns. The incidence of Mucormycosis is currently increasing reaching 7% of invasive fungal infections in some immunocompromised patients. Because of its aggressive nature, Mucormycosis is associated with poor survival and high morbidity ; mortality is estimated between 16% and 64% according to different retrospective studies. No study has ever evaluated prognosis of patients with mucormycosis admitted in intensive care units (ICU).
ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU and to evaluate the prognosis of different subgroups of patients according to :
- their clinical characteristics : demographic characteristics, clinical conditions and factors of immunosuppression
- the characteristics of the fungal infection
- the treatment strategy
- the severity of the initial illness, evaluated by severity scores
Twenty-one French ICU are currently including more than 45 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with mycormycosis hospitalized in intensive care unit during the 2008-2016 period
Key inclusion criteria (3 listed)
- confirmed or suspected mucormycosis, based on international definition from EORTC/MSG
- patient hospitalized in intensive care unit during the 2008-2016 period
- Zygomycosis identification in at least 2 solids organs or identification in hemoculture
Key exclusion criteria (2 listed)
- Age under 18 years old
- Patient under the law
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
Mortality at Day 28
Time frame: up to 28 days
Mortality at Day 28 after ICU admission
6 secondary outcomes
Mortality at Day 90
Time frame: up to 90 days
Mortality during the ICU stage
Time frame: up to 28 days
Length stay in ICU
Time frame: up to 28 days
Length stay of hospitalization
Time frame: up to 90 days
Mortality during the hospitalization
Time frame: up to 90 days
Prognostic criteria
Time frame: up to 28 days
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 8 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucormycosis, run by University Hospital, Grenoble at 21 sites 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 3 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
Mortality at Day 28 (time frame: up to 28 days). 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 8 Nov 2022.