BacteremiaBactHubNCT04065750
Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria
An observational study of Bacteremia, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The primary objective of the study is to identify the risk factors of community-acquired bacteremia to resistant bacteria. As the secondary objectives, the study aims to describe the episodes of epidemiology of bacteremia (community-acquired and nosocomial) with inpatient patients in APHP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 45,000 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2023to Dec 2023
- 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: Bacteremia cohort: all inpatient patients in a hospital of APHP between January 2010 and december 2018 with at least one haemoculture positive. Control cohort: patients cared in a hospital of APHP between 2010 and 2018 without infection.
Who may be able to join
- For bacteraemia cohort:
- All inpatient patients in a hospital of APHP between January 2010 and december 2018 with at least one haemoculture positive.
- presence of at least a bacteremia as primary diagnosis, related diagnosis and associated diagnosis: A40 (streptococcus), A41 (staphylococcus, BGN, anaerobes, others), A32.7 (Listeria), A39.4 (meningocoele), A42.7 (Actinomyces), A02.1 (Salmonella), A54.8 (gonocoque), A48.0 (Clostridium).
- and/or in biological data presence of at least a haemoculture positive to Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, Acinetobacter Baumannii, Enterococcus faecium, Enterococcus faecalis, Enterobacter cloacae, Pseudomonas aeruginosa, Streptococcus sp., Salmonella sp., Clostridium difficile.
- For control cohort:
- Patients cared in a hospital of APHP between 2010 and 2018 without infection. - Patients without infection of CIM-10 bacteraemia as primary diagnosis, related diagnosis and associated diagnosis, without haemoculture positive in microbiology.
Who cannot join
- Patients aged < 18 years
Trial locations and contacts
No sites are listed yet.
Salam Abbara, MD, PhD contact
About this study
The primary objective of the study is to identify the risk factors of community-acquired bacteremia to resistant bacteria.
As the secondary objectives, the study aims
- to describe the episodes of epidemiology of bacteremia (community-acquired and nosocomial) with inpatient patients in APHP.
- to research a potential correlation between the incidence of community-acquired bacteremia of studied germs and the evolution of antibiotics consumption in general population in Île de France region.
- to distinguish three categories of community-acquired bacteremia: real community-acquired infections, infections beginning in community (patients discharged a community care center within 3 months), the nosocomial infections (patients discharged a health center within 7 jours). Describe the epidemiology of resistance and the differential impact of individual exposure to antibiotics in these three categories.
- to identify, according to pathogens, a temporal threshold from which a prior stay in a health center or HAD would impact on the occurrence of a community-acquired bacteremia with a resistant bacterium.
- to describe prospectively for follow-up of 1 year for hospitalized patients for a community-acquired or nosocomial bacteremia: mortality at one month and 3 months, re-hospitalization for an infectious episode and isolated bacteria during this later episode.
Read the detailed description
The investigators will study in particularly individual exposure to antibiotics: exposure in 3 months ou in 12 months, cumulative exposure, hospital- and community-acquired exposure, etc.
- Conditions
- Bacteremia
- Keywords
- bacteremia, resistant bacteria, antibiotic
- Medical subject headings
- Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bacteraemia
Measured: through study completion, an average of 3 months
Secondary outcomes (2)
Mortality
Events of death will be recorded, the mortality rate will be calculated for 30 day and 90 day.
Measured: at 30 day and 90 day
Rehospitalization
The rate of 12 months unplanned rehospitalization for infection by the same biological pathogenes was recorded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start13 Nov 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Versailles Saint-Quentin-en-Yvelines University
- Responsible party
- Sponsor
- Investigators
- Laurence Watier, PhD, Study director, INSERM / Institut PasteurDidier Guillemont, MD, PhD, Principal investigator, APHP, Université de Versailles Saint-Quentin-en-Yvelines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065750
- Sponsor's protocol ID
- APHP190295
- Acronym
- BactHub
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2019
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria
- ClinicalTrials.gov ID
- NCT04065750
- Acronym / sponsor ID
- BactHub / APHP190295
- Conditions
- Bacteremia
- Keywords
- bacteremia, resistant bacteria, antibiotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Versailles Saint-Quentin-en-Yvelines University
- Study start
- 13 Nov 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Aug 2019 (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 primary objective of the study is to identify the risk factors of community-acquired bacteremia to resistant bacteria.
As the secondary objectives, the study aims
- to describe the episodes of epidemiology of bacteremia (community-acquired and nosocomial) with inpatient patients in APHP.
- to research a potential correlation between the incidence of community-acquired bacteremia of studied germs and the evolution of antibiotics consumption in general population in Île de France region.
- to distinguish three categories of community-acquired bacteremia: real community-acquired infections, infections beginning in community (patients discharged a community care center within 3 months), the nosocomial infections (patients discharged a health center within 7 jours). Describe the epidemiology of resistance and the differential impact of individual exposure to antibiotics in these three categories.
- to identify, according to pathogens, a temporal threshold from which a prior stay in a health center or HAD would impact on the occurrence of a community-acquired bacteremia with a resistant bacterium.
- to describe prospectively for follow-up of 1 year for hospitalized patients for a community-acquired or nosocomial bacteremia: mortality at one month and 3 months, re-hospitalization for an infectious episode and isolated bacteria during this later episode.
Detailed description
The investigators will study in particularly individual exposure to antibiotics: exposure in 3 months ou in 12 months, cumulative exposure, hospital- and community-acquired exposure, etc.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bacteremia cohort: all inpatient patients in a hospital of APHP between January 2010 and december 2018 with at least one haemoculture positive. Control cohort: patients cared in a hospital of APHP between 2010 and 2018 without infection.
Key inclusion criteria (6 listed)
- All inpatient patients in a hospital of APHP between January 2010 and december 2018 with at least one haemoculture positive.
- presence of at least a bacteremia as primary diagnosis, related diagnosis and associated diagnosis: A40 (streptococcus), A41 (staphylococcus, BGN, anaerobes, others), A32.7 (Listeria), A39.4 (meningocoele), A42.7 (Actinomyces), A02.1 (Salmonella), A54.8 (gonocoque), A48.0 (Clostridium).
- and/or in biological data presence of at least a haemoculture positive to Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, Acinetobacter Baumannii, Enterococcus faecium, Enterococcus faecalis, Enterobacter cloacae, Pseudomonas aeruginosa, Streptococcus sp., Salmonella sp., Clostridium difficile.
- Patients cared in a hospital of APHP between 2010 and 2018 without infection. - Patients without infection of CIM-10 bacteraemia as primary diagnosis, related diagnosis and associated diagnosis, without haemoculture positive in microbiology.
Key exclusion criteria (1 listed)
- Patients aged < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of bacteraemia
Time frame: through study completion, an average of 3 months
2 secondary outcomes
Mortality
Time frame: at 30 day and 90 day
Rehospitalization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
Salam Abbara, MD, PhD contact
Laurence Watier, PhD study director
INSERM / Institut Pasteur
Didier Guillemont, MD, PhD principal investigator
APHP, Université de Versailles Saint-Quentin-en-Yvelines
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Watier, PhD (+33 (0) 1 45 68 83 01, Laurence.watier@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bacteraemia (time frame: through study completion, an average of 3 months). 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 21 Sep 2023.