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Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria (BactHub)

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ClinicalTrials.gov Identifier: NCT04065750
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Versailles Saint-Quentin-en-Yvelines University
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease
Bacteremia

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.

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Study Type : Observational
Estimated Enrollment : 45000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. Incidence of bacteraemia [ Time Frame: through study completion, an average of 3 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: at 30 day and 90 day ]
    Events of death will be recorded, the mortality rate will be calculated for 30 day and 90 day.

  2. Rehospitalization [ Time Frame: 12 months ]
    The rate of 12 months unplanned rehospitalization for infection by the same biological pathogenes was recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065750


Contacts
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Contact: Laurence Watier, PhD +33 (0) 1 45 68 83 01 Laurence.watier@inserm.fr
Contact: Salam Abbara, MD, PhD

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Versailles Saint-Quentin-en-Yvelines University
Investigators
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Study Director: Laurence Watier, PhD INSERM / Institut Pasteur
Principal Investigator: Didier Guillemont, MD, PhD APHP, Université de Versailles Saint-Quentin-en-Yvelines
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04065750    
Other Study ID Numbers: 19SAA-BactHub
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
bacteremia
resistant bacteria
antibiotic
Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes