NCT06141837

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

November 14, 2023

Last Update Submit

May 6, 2024

Conditions

Keywords

ICU infectionsantimicrobial resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • P. aeruginosa sample

    From 01 March 2020 to 31 May 2021.

  • P. aeruginosa resistance

    From 01 March 2020 to 31 May 2021.

  • P. aeruginosa antibiotic treatment

    From 01 March 2020 to 31 May 2021.

  • P. aeruginosa recurrence

    From 01 March 2020 to 31 May 2021.

Study Arms (1)

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

Interventions

No intervention: observational study

Included

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 developed an hospital-acquired infection caused by P. aeruginosa during their stay in the intensive care unit.

You may qualify if:

  • Adult patients hospitalized for at least 48 h in an intensive care unit (ICU) at CHRU-Nancy for acute respiratory distress syndrome due to COVID-19.
  • Patients hospitalized from 1st March 2020 to 31st May 2021.
  • Patient developed an hospital-acquired infection caused by P. aeruginosa during their ICU stay.

You may not qualify if:

  • Patients \<18 years old.
  • Patient without COVID-19 at the ICU admission.
  • Patients with P. aeruginosa isolated \<48 hours following ICU admission.
  • Patients who did not want to be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pseudomonas InfectionsCOVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Arnaud Florentin, Dr

    a.florentin@chru-nancy.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 21, 2023

Study Start

December 1, 2023

Primary Completion

March 31, 2024

Study Completion

April 20, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05