Co-infection Management in COVID-19 Critically Ill

NCT04382092 | Completed

• 1 other identifier: 2019/14MAR/124
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

International guidelines suggest the administration of empirical broad-spectrum antibiotics for suspected bacterial co-infection in COVID-19 critically ill. However, data on associated respiratory infections is rare and antimicrobial stewardship interventions promoting antibiotic savings are non-existent in this context. The main objectives of the trial are: to evaluate the rate of co-infections among COVID-19 critically ill to evaluate the added value of a a rapid molecular diagnostic tool (FA-PNEU) to detect the presence of co-infecting pathogens in order to rapidly tailor the patient's antibiotic treatment

Conditions

COVID-19

Keywords

COVID-19; Pneumonia; Molecular Testing; Antimicrobial stewardship; FilmArray Pneumonia plus panel

Outcome Measures

Primary Outcomes (1)

• % of COVID-19 co-infections

  COVID-19 infections with additional bacteria/viruses identified through FA-PNEU testing

  through study completion, an average of 1 month

Secondary Outcomes (1)

• % of antibiotic switches following FA results

  through study completion, an average of 1 month

Study Arms (1)

Intervention COVID-19

EXPERIMENTAL

Respiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day.

Diagnostic Test: FilmArray Pneumonia

Interventions

FilmArray Pneumonia DIAGNOSTIC_TEST

Respiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day.

Intervention COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients remaining at the intensive care (SIM, SIT) of the CUSL with a confirmed COVID-19 infection

You may not qualify if:

• Patients from whom no respiratory sample can be obtained or
• Patients benefitting from palliative care or
• Insufficient volume of the respiratory sample after routine testing to perform the FA-PNEU test.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• BioMérieux: collaborator

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alexia VERROKEN, MD, PhD

  Cliniques universitaires St-Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective interventional study

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: March 23, 2020
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)