Pseudomonas Aeruginosa Infections Among COVID-19 Patients in Intensive Care Units at CHRU of Nancy (Pyo-COVID-3) (Pyo-COVID-3)

Pseudomonas Aeruginosa Infections Among COVID-19 Patients in Intensive Care Units at Nancy University Hospital During the First Three Epidemic Waves: a Retrospective Study (Pyo-COVID-3)

P. aeruginosa is an opportunistic bacterium known to be responsible for numerous healthcare-associated infections, particularly in intensive care units (ICU). The frequency of these infections seems to have increased during the first waves of the COVID-19 pandemic. Identifying cases of co-infection and secondary infections with P. aeruginosa in patients with COVID-19 would provide a better understanding of the epidemiological evolution and characteristics of infected patients.

Treatment of P. aeruginosa infections requires the use of antibiotics. Antibiotic resistance is a growing problem, with an increase in resistance among P. aeruginosa strains. The misuse of antibiotics to treat patients can accentuate the phenomenon of antibiotic resistance, and failure to take account of resistance revealed by antibiograms can compromise patient recovery. Analysis of bacteriological results and patient medical records would enable a posteriori evaluation of the proper use of antibiotics (choice and adaptation of molecules, doses and duration of prescriptions), and identify any areas for improvement.

The main objective is to describe the evolution of P. aeruginosa infections in ICU patients with COVID-19 during the first 3 waves of COVID-19 (01/03/2020 to 31/05/2021). Secondary objectives are to describe the typology of P. aeruginosa strains identified among included patients (sampling sites and resistance profiles), to assess antibiotic prescriptions for these patients and to describe the relapse rate of included patients with a first P. aeruginosa infection.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Pseudomonas Aeruginosa
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Arnaud Florentin, Dr; Phone Number: +33 383155293; Email: a.florentin@chru-nancy.fr

Study Locations

• France
  • Lorraine
    • Vandœuvre-lès-Nancy, Lorraine, France, 54500
      • Nancy University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patient hospitalized between 01/03/20 and 31/05/21 in an intensive care unit of the Nancy University Hospital for at less 48 h for COVID-19 acute respiratory distress syndrome and presenting a positive sample for P. aeruginosa during his/her stay in the intensive care unit.

Description

Inclusion Criteria:

• Patient hospitalized between 01/03/20 and 31/05/21 in anintensive care unit at Nancy University Hospital,
• Patient hospitalized for at less 48 h in an intensive care unit for COVID-19 acute respiratory distress syndrome,
• Patient with a positive P. aeruginosa sample during his/her stay in the intensive care unit.

Exclusion Criteria:

• Patient under 18 at time of hospitalization.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Included; Patient hospitalized between 01/03/20 and 31/05/21 in an intensive care unit of the Nancy University Hospital for at less 48 h for COVID-19 acute respiratory distress syndrome and presenting a positive sample for P. aeruginosa during his stay in the intensive care unit.	Other: Observation; No intervention: observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P. aeruginosa occurence	The occurrence of Pseudomonas aeruginosa infection during the ICU stay of a COVID-19 patient.	From 01 March 2020 to 31 May 2021.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P. aeruginosa sample	Distribution of different types of samples (respiratory, blood, urine, etc.) positive for P. aeruginosa.	From 01 March 2020 to 31 May 2021.
P. aeruginosa resistance	The proportion of resistance to the various antibiotics tested on the P. aeruginosa strains identified.	From 01 March 2020 to 31 May 2021.
P. aeruginosa antibiotic treatment	Compliance of antibiotic prescriptions with reference recommendations is assessed by comparing data from patients' medical records.	From 01 March 2020 to 31 May 2021.
P. aeruginosa recurrence	Occurrence of a new P. aeruginosa infection.	From 01 March 2020 to 31 May 2021.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Arnaud Florentin, Dr, a.florentin@chru-nancy.fr

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Estimated): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: antimicrobial resistance; ICU infections
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; COVID-19; Infections; Pseudomonas Infections
• Other Study ID Numbers: 2023PI186

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No