Skip to main content
OpenTrials
Completed

NCT Number: NCT03387696

Mucormycosis in ICU

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit - Hospital Amiens, Amiens, France

Loading trial locations.

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality at Day 28

    Time frame: up to 28 days

    Mortality at Day 28 after ICU admission

Secondary outcomes

  1. Mortality at Day 90

    Time frame: up to 90 days

    Mortality at Day 90 after ICU admission

  2. Mortality during the ICU stage

    Time frame: up to 28 days

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

  3. Length stay in ICU

    Time frame: up to 28 days

    number of days in intensive care Unit

  4. Length stay of hospitalization

    Time frame: up to 90 days

    number of days in hospital

  5. Mortality during the hospitalization

    Time frame: up to 90 days

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

  6. Prognostic criteria

    Time frame: up to 28 days

    Prognostic factors of mortality in intensive care units

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Mucormycosis in ICU: A French Multicenter Cohort Study

Acronym: ZygoRéa

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 2, 2018
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.