Mucormycosis in ICU | NCT03387696

Studies
Mucormycosis in ICU

NCT03387696

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Nov 8, 2022Actual

Enrollment

74Actual

Phase

Not provided

Conditions

Mucormycosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2017Actual

Primary Completion Date

Sep 10, 2017Actual

Completion Date

Jun 1, 2018Actual

First Submitted Date

Dec 1, 2017

First Submission Date that Met QC Criteria

Dec 22, 2017

First Posted Date

Jan 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2022

Last Update Posted Date

Nov 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality at Day 28	Mortality at Day 28 after ICU admission	up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
Mortality at Day 90	Mortality at Day 90 after ICU admission	up to 90 days
Mortality during the ICU stage	Mortality status (alive or dead) at the end of the ICU stage

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit - Hospital Amiens		Amiens			France
Intensive Care Unit - Hospital Angers

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009091	Mucormycosis

Ancestor Terms

ID	Term
D020096	Zygomycosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

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Browse Branches

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