ZygoRéa: Mucormycosis in ICU

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03387696
• Collaborator: (none)
• Enrollment: 50
• Locations: 21
• Anticipated Duration (Months): 8.7
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mucormycosis

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Mucormycosis in ICU: A French Multicenter Cohort Study
• Actual Study Start Date: Sep 8, 2017
• Anticipated Primary Completion Date: May 1, 2018
• Anticipated Study Completion Date: Jun 1, 2018

Outcome Measures

Primary Outcome Measures

1. Mortality at Day 28 [up to 28 days]

   Mortality at Day 28 after ICU admission

Secondary Outcome Measures

1. Mortality at Day 90 [up to 90 days]

   Mortality at Day 90 after ICU admission

2. Mortality during the ICU stage [up to 28 days]

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

3. Length stay in ICU [up to 28 days]

   number of days in intensive care Unit

4. Length stay of hospitalization [up to 90 days]

   number of days in hospital

5. Mortality during the hospitalization [up to 90 days]

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

6. Prognostic criteria [up to 28 days]

   Prognostic factors of mortality in intensive care units

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intensive Care Unit - Hospital Amiens	Amiens		France
2	Intensive Care Unit - Hospital Angers	Angers		France
3	Intensive Care Unit - Hospital Besançon	Besançon		France
4	Intensive Care Unit - Hospital Béthune	Béthune		France
5	Intensive Care Unit - Hospital Caen	Caen		France
6	Intensive Care Unit - Hospital Clermont-Ferrand	Clermont-Ferrand		France
7	Intensive Care Unit - Hospital Dijon	Dijon		France
8	Intensive Care Unit - Hospital Grenoble Alpes	Grenoble		France
9	Intensive Care Unit - Hospital Lille	Lille		France
10	Intensive Care Unit - Hospital Lyon	Lyon		France
11	Intensive Care Unit - Hospital Montpellier	Montpellier		France
12	Intensive Care Unit - Hospital Nantes	Nantes		France
13	Intensive Care Unit - Hospital l'Archet - Nice	Nice		France
14	Intensive Care Unit - Hospital Bichat	Paris		France
15	Intensive Care Unit - Hospital Saint Louis	Paris		France
16	Intensive Care Unit - Hospital Tenon	Paris		France
17	Intensive Care Unit - Hospital Poitiers	Poitiers		France
18	Intensive Care Unit - Hospital Rennes	Rennes		France
19	Intensive Care Unit - Hospital Rouen	Rouen		France
20	Intensive Care Unit - Hospital Saint Etienne	Saint-Étienne		France
21	Intensive Care Unit - Hospital Tours	Tours		France

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT03387696
• Other Study ID Numbers: ZygoRea (38RC17.008)
• First Posted: Jan 2, 2018
• Last Update Posted: Jan 2, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Grenoble: Mucormycosis; Intensive Care Medicine
• Additional relevant MeSH terms: Mucormycosis; Zygomycosis

Study Results

No Results Posted as of Jan 2, 2018