NCT04368221

Brief Summary

Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

Trial Health

87
On Track

Trial Health Score

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

Enrollment
576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

22 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

First Submitted

Initial submission to the registry

April 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

April 24, 2020

Last Update Submit

March 29, 2021

Conditions

Covid-19

Keywords

Invasives mycosesaspergillosispneumocystosismucormycosis

Outcome Measures

Primary Outcomes (1)

  • Opportunistic fungal co-infections.

    Prevalence of opportunistic fungal co-infections.

    at 12 months

Secondary Outcomes (3)

  • Median time

    at 12 months

  • Time between diagnosis and targeted treatment

    at ICU discharge, up to 1 month

  • Preventive strategies

    At 12 months

Eligibility Criteria

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

COVID-19 patients hospitalized in ICU for ARDS

You may qualify if:

  • ICU patients COVID-19 diagnosed by RT-PCR
  • Intubated and mechanically ventilated patients
  • Adult patients
  • Patients (or legal representative) informed on the research without opposition
  • Patients \<18 years old
  • People of full age who are the subject of a judicial safeguard,

You may not qualify if:

  • Patient, or legal representative opposing the pursuit of the research
  • Patients under judicial protection will be excluded as soon as the investigator becomes aware of their status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

CHU Angers

Angers, France

Location

CHU de Brest

Brest, France

Location

CHU de Dijon

Dijon, France

Location

CHU Grenoble

Grenoble, France

Location

CHU Lille

Lille, France

Location

CHU Lyon

Lyon, France

Location

CHU Marseille

Marseille, France

Location

CHU Nantes

Nantes, France

Location

CHU de Nice

Nice, France

Location

CHU Paris - Avicenne

Paris, France

Location

CHU Paris - Bichat

Paris, France

Location

CHU Paris - HEGP

Paris, France

Location

CHU Paris - Mondor

Paris, France

Location

CHU Paris - Tenon

Paris, France

Location

Hôpital Lariboisière/ St Louis

Paris, France

Location

Hôpital Necker-Enfants Malades

Paris, France

Location

Hôpital Pitié-Salpêtrière

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, 35033, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

Related Publications (1)

  • Gangneux JP, Dannaoui E, Fekkar A, Luyt CE, Botterel F, De Prost N, Tadie JM, Reizine F, Houze S, Timsit JF, Iriart X, Riu-Poulenc B, Sendid B, Nseir S, Persat F, Wallet F, Le Pape P, Canet E, Novara A, Manai M, Cateau E, Thille AW, Brun S, Cohen Y, Alanio A, Megarbane B, Cornet M, Terzi N, Lamhaut L, Sabourin E, Desoubeaux G, Ehrmann S, Hennequin C, Voiriot G, Nevez G, Aubron C, Letscher-Bru V, Meziani F, Blaize M, Mayaux J, Monsel A, Boquel F, Robert-Gangneux F, Le Tulzo Y, Seguin P, Guegan H, Autier B, Lesouhaitier M, Pelletier R, Belaz S, Bonnal C, Berry A, Leroy J, Francois N, Richard JC, Paulus S, Argaud L, Dupont D, Menotti J, Morio F, Soulie M, Schwebel C, Garnaud C, Guitard J, Le Gal S, Quinio D, Morcet J, Laviolle B, Zahar JR, Bougnoux ME. Fungal infections in mechanically ventilated patients with COVID-19 during the first wave: the French multicentre MYCOVID study. Lancet Respir Med. 2022 Feb;10(2):180-190. doi: 10.1016/S2213-2600(21)00442-2. Epub 2021 Nov 26.

    PMID: 34843666DERIVED

MeSH Terms

Conditions

COVID-19AspergillosisPneumonia, PneumocystisMucormycosis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMycosesBacterial Infections and MycosesLung Diseases, FungalPneumocystis InfectionsZygomycosis

Study Design

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

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 29, 2020

Study Start

May 4, 2020

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

FR(22)