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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06141837
Collaborator
(none)
55
1
2
27.4

Study Details

Study Description

Brief Summary

  1. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation

Study Design

Study Type:
Observational
Anticipated Enrollment :
55 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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)
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. P. aeruginosa occurence [From 01 March 2020 to 31 May 2021.]

    The occurrence of Pseudomonas aeruginosa infection during the ICU stay of a COVID-19 patient.

Secondary Outcome Measures

  1. P. aeruginosa sample [From 01 March 2020 to 31 May 2021.]

    Distribution of different types of samples (respiratory, blood, urine, etc.) positive for P. aeruginosa.

  2. P. aeruginosa resistance [From 01 March 2020 to 31 May 2021.]

    The proportion of resistance to the various antibiotics tested on the P. aeruginosa strains identified.

  3. P. aeruginosa antibiotic treatment [From 01 March 2020 to 31 May 2021.]

    Compliance of antibiotic prescriptions with reference recommendations is assessed by comparing data from patients' medical records.

  4. P. aeruginosa recurrence [From 01 March 2020 to 31 May 2021.]

    Occurrence of a new P. aeruginosa infection.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nancy University Hospital Vandœuvre-lès-Nancy Lorraine France 54500

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Arnaud Florentin, Dr, a.florentin@chru-nancy.fr

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
FLORENTIN Arnaud, Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT06141837
Other Study ID Numbers:
  • 2023PI186
First Posted:
Nov 21, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by FLORENTIN Arnaud, Doctor, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2023