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CompletedNCT03387696ZygoRéaUpdated Nov 8, 2022

Mucormycosis in ICU

An observational study in Mucormycosis, sponsored by University Hospital, Grenoble. Completed at 21 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
74
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Mucormycosis

Keywords

  • Mucormycosis
  • Intensive Care Medicine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Age under 18 years old
  • Patient under the law
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
74 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Mortality at Day 28

    Mortality at Day 28 after ICU admission

    Time frame: up to 28 days

Secondary outcomes

  1. Mortality at Day 90

    Mortality at Day 90 after ICU admission

    Time frame: up to 90 days

  2. Mortality during the ICU stage

    Mortality status (alive or dead) at the end of the ICU stage

    Time frame: up to 28 days

  3. Length stay in ICU

    number of days in intensive care Unit

    Time frame: up to 28 days

  4. Length stay of hospitalization

    number of days in hospital

    Time frame: up to 90 days

  5. Mortality during the hospitalization

    Mortality status (alive or dead) at the end of the hospitalization

    Time frame: up to 90 days

  6. Prognostic criteria

    Prognostic factors of mortality in intensive care units

    Time frame: up to 28 days

06

Study locations

21 sites
  • 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, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03387696
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Jan 2, 2018
Start date
Sep 8, 2017
Primary completion
Sep 10, 2017
Completion
Jun 1, 2018
Last update
Nov 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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