Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria

NCT ID: NCT04065750

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2023-12-31

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.

Conditions

Bacteremia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Versailles Saint-Quentin-en-Yvelines University

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Watier, PhD

Role: STUDY_DIRECTOR

INSERM / Institut Pasteur

Didier Guillemont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP, Université de Versailles Saint-Quentin-en-Yvelines

Central Contacts

Laurence Watier, PhD

Role: CONTACT

Laurence.watier@inserm.fr

+33 (0) 1 45 68 83 01

Salam Abbara, MD, PhD

Role: CONTACT

Other Identifiers

APHP190295

Identifier Type: -

Identifier Source: org_study_id