NCT03387696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

2 days

First QC Date

December 1, 2017

Last Update Submit

November 7, 2022

Conditions

Mucormycosis

Keywords

MucormycosisIntensive Care Medicine

Outcome Measures

Primary Outcomes (1)

  • Mortality at Day 28

    Mortality at Day 28 after ICU admission

    up to 28 days

Secondary Outcomes (6)

  • Mortality at Day 90

    up to 90 days

  • Mortality during the ICU stage

    up to 28 days

  • Length stay in ICU

    up to 28 days

  • Length stay of hospitalization

    up to 90 days

  • Mortality during the hospitalization

    up to 90 days

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Age under 18 years old
  • Patient under the law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Intensive Care Unit - Hospital Amiens

Amiens, France

Location

Intensive Care Unit - Hospital Angers

Angers, France

Location

Intensive Care Unit - Hospital Besançon

Besançon, France

Location

Intensive Care Unit - Hospital Béthune

Béthune, France

Location

Intensive Care Unit - Hospital Caen

Caen, France

Location

Intensive Care Unit - Hospital Clermont-Ferrand

Clermont-Ferrand, France

Location

Intensive Care Unit - Hospital Dijon

Dijon, France

Location

Intensive Care Unit - Hospital Grenoble Alpes

Grenoble, France

Location

Intensive Care Unit - Hospital Lille

Lille, France

Location

Intensive Care Unit - Hospital Lyon

Lyon, France

Location

Intensive Care Unit - Hospital Montpellier

Montpellier, France

Location

Intensive Care Unit - Hospital Nantes

Nantes, France

Location

Intensive Care Unit - Hospital l'Archet - Nice

Nice, France

Location

Intensive Care Unit - Hospital Bichat

Paris, France

Location

Intensive Care Unit - Hospital Saint Louis

Paris, France

Location

Intensive Care Unit - Hospital Tenon

Paris, France

Location

Intensive Care Unit - Hospital Poitiers

Poitiers, France

Location

Intensive Care Unit - Hospital Rennes

Rennes, France

Location

Intensive Care Unit - Hospital Rouen

Rouen, France

Location

Intensive Care Unit - Hospital Saint Etienne

Saint-Etienne, France

Location

Intensive Care Unit - Hospital Tours

Tours, France

Location

MeSH Terms

Conditions

Mucormycosis

Condition Hierarchy (Ancestors)

ZygomycosisMycosesBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2017

First Posted

January 2, 2018

Study Start

September 8, 2017

Primary Completion

September 10, 2017

Study Completion

June 1, 2018

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(21)