Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria

Bacteremia Clinical Trial

— BactHub  

Official title:

Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04065750
• Other study ID #: APHP190295
• Status: Not yet recruiting
• Start date: November 13, 2023
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Laurence Watier, PhD
• Phone: +33 (0) 1 45 68 83 01
• Email: Laurence.watier[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, Versailles Saint-Quentin-en-Yvelines University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bacteraemia		through study completion, an average of 3 months
Secondary	Mortality	Events of death will be recorded, the mortality rate will be calculated for 30 day and 90 day.	at 30 day and 90 day
Secondary	Rehospitalization	The rate of 12 months unplanned rehospitalization for infection by the same biological pathogenes was recorded.	12 months