NCT04647539

Brief Summary

Rationale: Beside Candida and Aspergillus, emerging invasive fungal infections (EIFIs) are increasing in intensive care setting and are associated with high morbidity and mortality. However, data are scarce, particularly in ICU settings and for EIFIs other than mucormycosis. Objectives: to describe epidemiological trends and clinical features of EIFIs in intensive care units (ICU) and to assess their outcome. Methods: All records of adult patients diagnosed with an EIFI in a medical ICU between 2006 and 2019 were analyzed retrospectively. In-ICU mortality was assessed, then factors associated with mortality were identified. Survival at day-90 was calculated by the Kaplan-Meier method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2006

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

13.9 years

First QC Date

November 23, 2020

Last Update Submit

November 23, 2020

Conditions

Fungal InfectionICU Acquired Weakness

Keywords

Emergind invasive fungal infectionmucormycosisICU

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality

    at ICU admission

Secondary Outcomes (1)

  • Mucormycosis

    at ICU admission

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients majeurs hospitalisés en reanimation et présentant une infection fongique invasive autre qu'une candidose ou une aspergilloses

You may qualify if:

  • \- Adults (≥ 18 years old) with at least 1 positive culture for molds other than candida and aspergillosis

You may not qualify if:

  • \- Age \< 18, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

MycosesMucormycosis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsZygomycosis

Study Officials

  • Romaric Larcher, MD, PharmD, MSc

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

January 1, 2006

Primary Completion

December 1, 2019

Study Completion

November 23, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

FR(1)