Mucormycosis in ICU

Completed

• Conditions: Mucormycosis

• Registration Number: NCT03387696
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

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 Timeline

• Study Start: 2017-09-08
• Primary Completion: 2017-09-10
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Study Completion: 2018-06-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at Day 28	up to 28 days	Mortality at Day 28 after ICU admission

Secondary Outcome Measures

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

Trial Locations

Locations (21)

Intensive Care Unit - Hospital l'Archet - Nice; 🇫🇷 Nice, France

Intensive Care Unit - Hospital Rouen; 🇫🇷 Rouen, France

Intensive Care Unit - Hospital Bichat; 🇫🇷 Paris, France

Intensive Care Unit - Hospital Tenon; 🇫🇷 Paris, France

Intensive Care Unit - Hospital Montpellier; 🇫🇷 Montpellier, France

Intensive Care Unit - Hospital Nantes; 🇫🇷 Nantes, France

Intensive Care Unit - Hospital Tours; 🇫🇷 Tours, France

Intensive Care Unit - Hospital Saint Louis; 🇫🇷 Paris, France

Intensive Care Unit - Hospital Rennes; 🇫🇷 Rennes, 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 Dijon; 🇫🇷 Dijon, France

Intensive Care Unit - Hospital Caen; 🇫🇷 Caen, France

Intensive Care Unit - Hospital Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Intensive Care Unit - Hospital Grenoble Alpes; 🇫🇷 Grenoble, France

Intensive Care Unit - Hospital Lyon; 🇫🇷 Lyon, France

Intensive Care Unit - Hospital Poitiers; 🇫🇷 Poitiers, France

Intensive Care Unit - Hospital Saint Etienne; 🇫🇷 Saint-Étienne, France

Intensive Care Unit - Hospital Lille; 🇫🇷 Lille, France