Clinical trial NCT03387696: Mucormycosis in ICU
Official title: Mucormycosis in ICU: A French Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucormycosis
Keywords: Mucormycosis
Intensive Care Medicine
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with mycormycosis hospitalized in intensive care unit during the 2008-2016 period

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality at Day 28
timeFrame: up to 28 days
Secondary outcomes:
measure: Mortality at Day 90
timeFrame: up to 90 days
measure: Mortality during the ICU stage
timeFrame: up to 28 days
measure: Length stay in ICU
timeFrame: up to 28 days
measure: Length stay of hospitalization
timeFrame: up to 90 days
measure: Mortality during the hospitalization
timeFrame: up to 90 days
measure: Prognostic criteria
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: Intensive Care Unit - Hospital Amiens
city: Angers
country: France
facility: Intensive Care Unit - Hospital Angers
city: Besançon
country: France
facility: Intensive Care Unit - Hospital Besançon
city: Béthune
country: France
facility: Intensive Care Unit - Hospital Béthune
city: Caen
country: France
facility: Intensive Care Unit - Hospital Caen
city: Clermont-Ferrand
country: France
facility: Intensive Care Unit - Hospital Clermont-Ferrand
city: Dijon
country: France
facility: Intensive Care Unit - Hospital Dijon
city: Grenoble
country: France
facility: Intensive Care Unit - Hospital Grenoble Alpes
city: Lille
country: France
facility: Intensive Care Unit - Hospital Lille
city: Lyon
country: France
facility: Intensive Care Unit - Hospital Lyon
city: Montpellier
country: France
facility: Intensive Care Unit - Hospital Montpellier
city: Nantes
country: France
facility: Intensive Care Unit - Hospital Nantes
city: Nice
country: France
facility: Intensive Care Unit - Hospital l'Archet - Nice
city: Paris
country: France
facility: Intensive Care Unit - Hospital Bichat
city: Paris
country: France
facility: Intensive Care Unit - Hospital Saint Louis
city: Paris
country: France
facility: Intensive Care Unit - Hospital Tenon
city: Poitiers
country: France
facility: Intensive Care Unit - Hospital Poitiers
city: Rennes
country: France
facility: Intensive Care Unit - Hospital Rennes
city: Rouen
country: France
facility: Intensive Care Unit - Hospital Rouen
city: Saint-Étienne
country: France
facility: Intensive Care Unit - Hospital Saint Etienne
city: Tours
country: France
facility: Intensive Care Unit - Hospital Tours
Study officials:
References: