BacteremiaNCT05640349
Evaluation of Bacteremia Epidemiology During the COVID Period in One French University Hospital
An observational study of Bacteremia and Catheter-Related Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The main objective of this retrospective cohort is to evaluate the impact of the first epidemic wave during lockdown on bacteremia epidemiology in one French University Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacteremia, Catheter-Related Infections
- What is being tested?
- Positive blood culture
- How many people
- 4,200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2022to 30 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of University Hospital of Nice
- Inclusion criteria : Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice Aged 18 years
- Exclusion criteria : Patients with negative blood culture recorded at the microbiology laboratory of University Hospital of Nice
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this retrospective cohort is to evaluate the impact of the first epidemic wave during lockdown on bacteremia epidemiology in one French University Hospital.
- Conditions
- Bacteremia, Catheter-Related Infections
- Being tested
- Positive blood culture
- Medical subject headings
- Bacteremia, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive blood cultureBiological
Positive blood culture recorded at the microbiology laboratory of University Hospital of Nic
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice during the Covid-19 Pandemic lockdown (between 23/03/2020 and 24/05/2020). Receives: Biological: Positive blood culture | |
| Control | Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice between 23/03/2019 and 24/05/2019. Receives: Biological: Positive blood culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of bacteriemia,catheter-related infection and contamination
Describe and compare the incidence and epidemiology of hospital-diagnosed bacteriemia, catheter-related infection and contamination
Measured: Day 0
Secondary outcomes (2)
Characterization of community bacteremia
Measured: Day 0
Determined therapeutic actions
Anticipate the diagnostic and therapeutic actions to be taken for future epidemics
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start15 Apr 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640349
- Sponsor's protocol ID
- 22Infectio02
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bacteremia Epidemiology During the COVID Period in One French University Hospital
- ClinicalTrials.gov ID
- NCT05640349
- Acronym / sponsor ID
- 22Infectio02
- Conditions
- Bacteremia, Catheter-Related Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 Dec 2022 (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.
The main objective of this retrospective cohort is to evaluate the impact of the first epidemic wave during lockdown on bacteremia epidemiology in one French University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Biological: Positive blood culturePatients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice during the Covid-19 Pandemic lockdown (between 23/03/2020 and 24/05/2020). |
| Control | – | Biological: Positive blood culturePatients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice between 23/03/2019 and 24/05/2019. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of University Hospital of Nice
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 |
|---|---|---|
| Positive blood culturePositive blood culture recorded at the microbiology laboratory of University Hospital of Nic | Biological | Case, Control |
Primary outcome
Epidemiology of bacteriemia,catheter-related infection and contamination
Time frame: Day 0
Describe and compare the incidence and epidemiology of hospital-diagnosed bacteriemia, catheter-related infection and contamination
2 secondary outcomes
Characterization of community bacteremia
Time frame: Day 0
Determined therapeutic actions
Time frame: Day 0
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 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia and Catheter-Related Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Epidemiology of bacteriemia,catheter-related infection and contamination (time frame: Day 0). 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 Dec 2022.