Clinical trial NCT04065750: Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria
Official title: Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bacteremia
Keywords: bacteremia
resistant bacteria
antibiotic
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Versailles Saint-Quentin-en-Yvelines University
First posted: 2019-08-22
Enrollment: 45000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.
* 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

- Patients aged \< 18 years

Primary outcomes:
measure: Incidence of bacteraemia
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Mortality
timeFrame: at 30 day and 90 day
measure: Rehospitalization
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: INSERM / Institut Pasteur
name: Laurence Watier, PhD
role: STUDY_DIRECTOR
affiliation: APHP, Université de Versailles Saint-Quentin-en-Yvelines
name: Didier Guillemont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: