Mucormycosis in ICU (ZygoRéa)

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.

Study Overview

• Status: Completed
• Conditions: Mucormycosis

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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with mycormycosis hospitalized in intensive care unit during the 2008-2016 period

Description

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

Study Plan

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
Mortality at Day 28	Mortality at Day 28 after ICU admission	up to 28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2017
• Primary Completion (Actual): September 10, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Mucormycosis; Intensive Care Medicine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Mucormycosis; Zygomycosis
• Other Study ID Numbers: ZygoRea (38RC17.008)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No