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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06141837
Other study ID # 2023PI186
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date April 20, 2024

Study information

Verified date May 2024
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date April 20, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Observation
No intervention: observational study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary P. aeruginosa recurrence Occurrence of a new P. aeruginosa infection. From 01 March 2020 to 31 May 2021.
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