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Clinical Trials/NCT04065750
NCT04065750
Not yet recruiting
Not Applicable

Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria

Assistance Publique - Hôpitaux de Paris0 sites45,000 target enrollmentNovember 13, 2023
ConditionsBacteremia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bacteremia
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
45000
Primary Endpoint
Incidence of bacteraemia
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2023
End Date
December 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Incidence of bacteraemia

Time Frame: through study completion, an average of 3 months

Secondary Outcomes

  • Mortality(at 30 day and 90 day)
  • Rehospitalization(12 months)

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