Co-infection Management in COVID-19 Critically Ill
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
FilmArray Pneumonia
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 focused on measuring COVID-19, Pneumonia, Molecular Testing, Antimicrobial stewardship, FilmArray Pneumonia plus panel
Eligibility Criteria
Inclusion Criteria:
- Adult patients remaining at the intensive care (SIM, SIT) of the CUSL with a confirmed COVID-19 infection
Exclusion Criteria:
- 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.
Sites / Locations
- Cliniques Universitaires Saint-Luc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention COVID-19
Arm Description
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.
Outcomes
Primary Outcome Measures
% of COVID-19 co-infections
COVID-19 infections with additional bacteria/viruses identified through FA-PNEU testing
Secondary Outcome Measures
% of antibiotic switches following FA results
The rapid FA results could allow a fast modification of the empirical antibiotherapy. This percentage will be measured.
Full Information
NCT ID
NCT04382092
First Posted
May 6, 2020
Last Updated
May 8, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
BioMérieux
1. Study Identification
Unique Protocol Identification Number
NCT04382092
Brief Title
Co-infection Management in COVID-19 Critically Ill
Official Title
Co-infections in COVID-19 Critically Ill and Antibiotic Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
April 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
BioMérieux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
At the end of April 2020, the World Health Organisation reported that nearly three million people worldwide were infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) of whom 202 000 people already died from the associated disease named COVID-19. Clinical presentation varies from asymptomatic carriage to a severe respiratory infection with an acute respiratory distress syndrome and it has been calculated that approximately 5% of COVID-19 patients require intensive care. Dramatically, the reported mortality rate 28 days following admission upon the intensive care unit (ICU) is as high as 61.5%.
The 23th of March, an expert team of the Surviving Sepsis Campaign (SSC) has released a series of guidelines on the management of COVID-19 in critically ill in which they address recommendations on infection control and testing, hemodynamic control, ventilatory support and therapy. Considering the latter, the use of empiric antimicrobial/antibacterial agents is suggested among patients who have respiratory failure requiring mechanical ventilation because of suspected co-infection. Reported rates of bacterial co-infection in Influenza A patients range from 6 to 65%. It could be thought that SARS-CoV-2 destroys the respiratory epithelium in a similar way thereby facilitating bacterial invasion. SSC experts further suggest to assess for de-escalation. Rationally the adjustment to a targeted antibiotherapy requires a microbiological diagnosis of the suspected bacterial co-infection. Contemporary laboratory culture-based testing on lower respiratory tract samples requires a minimum of 24-48 hours to obtain respectively identification and antimicrobial susceptibility results. During this incompressible time interval, administration of broad-spectrum antibiotics is maintained with a risk of selecting multi-resistant bacteria potentially causing nosocomial infections. Aiming to reduce time of microbiological analysis, molecular tools have been very recently developed allowing the detection of a panel of microorganisms including bacteria and viruses directly from a lower respiratory tract sample within a few hours. Recent evaluations reported satisfying performances compared to routine microbiological methods and forecasted a substantial benefit of molecular testing in the speeded-up instauration of a targeted antibiotherapy and isolation precautions in patients with lower respiratory tract infections.
In this prospective clinical trial, the investigators performed a rapid molecular test on the initial lower respiratory sample of each COVID-19 patient admitted to ICU. The primary objective of the study was to determine the rate of co-infections in COVID-19 critically ill and the secondary objective was to measure the impact of the rapid molecular diagnostic test on the antimicrobial management of all included patients. The investigators hypothesized the rapid results of the detected pathogens will support the intensive care physician in the initiation of a targeted antibiotic treatment but also in the weaning of any antibiotherapy if all microorganisms remain undetected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Pneumonia, Molecular Testing, Antimicrobial stewardship, FilmArray Pneumonia plus panel
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention COVID-19
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
FilmArray Pneumonia
Intervention Description
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.
Primary Outcome Measure Information:
Title
% of COVID-19 co-infections
Description
COVID-19 infections with additional bacteria/viruses identified through FA-PNEU testing
Time Frame
through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
% of antibiotic switches following FA results
Description
The rapid FA results could allow a fast modification of the empirical antibiotherapy. This percentage will be measured.
Time Frame
through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients remaining at the intensive care (SIM, SIT) of the CUSL with a confirmed COVID-19 infection
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexia VERROKEN, MD, PhD
Organizational Affiliation
Cliniques universitaires St-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Co-infection Management in COVID-19 Critically Ill
We'll reach out to this number within 24 hrs