Mucormycosis in ICU

Mucormycosis Clinical Trial

— ZygoRéa  

Official title:

Mucormycosis in ICU: A French Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387696
• Other study ID #: ZygoRea (38RC17.008)
• Status: Completed
• Start date: September 8, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: November 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 1, 2018
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age under 18 years old

• Patient under the law

Related Conditions & MeSH terms

• Mucormycosis
• Zygomycosis

Locations

Country	Name	City	State
France	Intensive Care Unit - Hospital Amiens	Amiens
France	Intensive Care Unit - Hospital Angers	Angers
France	Intensive Care Unit - Hospital Besançon	Besançon
France	Intensive Care Unit - Hospital Béthune	Béthune
France	Intensive Care Unit - Hospital Caen	Caen
France	Intensive Care Unit - Hospital Clermont-Ferrand	Clermont-Ferrand
France	Intensive Care Unit - Hospital Dijon	Dijon
France	Intensive Care Unit - Hospital Grenoble Alpes	Grenoble
France	Intensive Care Unit - Hospital Lille	Lille
France	Intensive Care Unit - Hospital Lyon	Lyon
France	Intensive Care Unit - Hospital Montpellier	Montpellier
France	Intensive Care Unit - Hospital Nantes	Nantes
France	Intensive Care Unit - Hospital l'Archet - Nice	Nice
France	Intensive Care Unit - Hospital Bichat	Paris
France	Intensive Care Unit - Hospital Saint Louis	Paris
France	Intensive Care Unit - Hospital Tenon	Paris
France	Intensive Care Unit - Hospital Poitiers	Poitiers
France	Intensive Care Unit - Hospital Rennes	Rennes
France	Intensive Care Unit - Hospital Rouen	Rouen
France	Intensive Care Unit - Hospital Saint Etienne	Saint-Étienne
France	Intensive Care Unit - Hospital Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at Day 28	Mortality at Day 28 after ICU admission	up to 28 days
Secondary	Mortality at Day 90	Mortality at Day 90 after ICU admission	up to 90 days
Secondary	Mortality during the ICU stage	Mortality status (alive or dead) at the end of the ICU stage	up to 28 days
Secondary	Length stay in ICU	number of days in intensive care Unit	up to 28 days
Secondary	Length stay of hospitalization	number of days in hospital	up to 90 days
Secondary	Mortality during the hospitalization	Mortality status (alive or dead) at the end of the hospitalization	up to 90 days
Secondary	Prognostic criteria	Prognostic factors of mortality in intensive care units	up to 28 days