Pseudomonas AeruginosaPyo-COVID-3NCT06141837
Pseudomonas Aeruginosa Infections Among COVID-19 Patients in Intensive Care Units at CHRU of Nancy (Pyo-COVID-3)
An observational study of Pseudomonas Aeruginosa and COVID-19, run by Central Hospital, Nancy, France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomonas Aeruginosa, COVID-19
- What is being tested?
- Observation
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 20 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
- 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.
- Conditions
- Pseudomonas Aeruginosa, COVID-19
- Being tested
- Observation
- Keywords
- ICU infections, antimicrobial resistance
- Medical subject headings
- Pseudomonas Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No intervention: observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
P. aeruginosa occurence
The occurrence of Pseudomonas aeruginosa infection during the ICU stay of a COVID-19 patient.
Measured: From 01 March 2020 to 31 May 2021.
Secondary outcomes (4)
P. aeruginosa sample
Distribution of different types of samples (respiratory, blood, urine, etc.) positive for P. aeruginosa.
Measured: 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.
Measured: 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.
Measured: From 01 March 2020 to 31 May 2021.
P. aeruginosa recurrence
Occurrence of a new P. aeruginosa infection.
Measured: From 01 March 2020 to 31 May 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023
- Primary completion31 Mar 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas AeruginosaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FLORENTIN Arnaud, Central Hospital, Nancy, France
- Investigators
- Arnaud Florentin, Dr, Principal investigator, a.florentin@chru-nancy.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141837
- Sponsor's protocol ID
- 2023PI186
- Acronym
- Pyo-COVID-3
- Status last verified
- May 2024
- First submitted
- 14 Nov 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06141837
- Acronym / sponsor ID
- Pyo-COVID-3 / 2023PI186
- Conditions
- Pseudomonas Aeruginosa, COVID-19
- Keywords
- ICU infections, antimicrobial resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included | – | Other: ObservationPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo intervention: observational study | Other | Included |
Primary outcome
P. aeruginosa occurence
Time frame: From 01 March 2020 to 31 May 2021.
The occurrence of Pseudomonas aeruginosa infection during the ICU stay of a COVID-19 patient.
4 secondary outcomes
P. aeruginosa sample
Time frame: From 01 March 2020 to 31 May 2021.
P. aeruginosa resistance
Time frame: From 01 March 2020 to 31 May 2021.
P. aeruginosa antibiotic treatment
Time frame: From 01 March 2020 to 31 May 2021.
P. aeruginosa recurrence
Time frame: From 01 March 2020 to 31 May 2021.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Florentin, Dr principal investigator
a.florentin@chru-nancy.fr
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudomonas Aeruginosa and COVID-19, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P. aeruginosa occurence (time frame: From 01 March 2020 to 31 May 2021.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.