Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria

NCT04065750 | Unknown

• 1 other identifier: APHP190295
• Study Type: observational
• Target: 45,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacteremia

Keywords

bacteremia; resistant bacteria; antibiotic

Outcome Measures

Primary Outcomes (1)

• Incidence of bacteraemia

  through study completion, an average of 3 months

Secondary Outcomes (2)

• Mortality

  at 30 day and 90 day

• Rehospitalization

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Patients aged \< 18 years

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Versailles Saint-Quentin-en-Yvelines University: collaborator

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurence Watier, PhD

  INSERM / Institut Pasteur

  STUDY DIRECTOR

• Didier Guillemont, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Watier, PhD

CONTACT

+33 (0) 1 45 68 83 01; Laurence.watier@inserm.fr

Salam Abbara, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 22, 2019
• Study Start: November 13, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share