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Not yet recruitingNCT04065750BactHubUpdated Sep 21, 2023

Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria

An observational study in Bacteremia, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
45,000
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Bacteremia

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Keywords

  • bacteremia
  • resistant bacteria
  • antibiotic
03

In context

Bacteremia

297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.

This study's planned enrollment of 45,000 is above the median of 300 across 125 observational studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients aged \< 18 years
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
45,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of bacteraemia

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

Secondary outcomes

  1. Mortality

    Events of death will be recorded, the mortality rate will be calculated for 30 day and 90 day.

    Time frame: at 30 day and 90 day

  2. Rehospitalization

    The rate of 12 months unplanned rehospitalization for infection by the same biological pathogenes was recorded.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04065750
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Versailles Saint-Quentin-en-Yvelines University
Responsible party
Sponsor
First posted
Aug 22, 2019
Start date
Nov 13, 2023 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Sep 21, 2023

Study contacts

Laurence Watier, PhD
Contact
Laurence.watier@inserm.fr
+33 (0) 1 45 68 83 01
Salam Abbara, MD, PhD
Contact
Laurence Watier, PhD
study director · INSERM / Institut Pasteur
Didier Guillemont, MD, PhD
principal investigator · APHP, Université de Versailles Saint-Quentin-en-Yvelines

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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