Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-06

Study Completion Date

2018-07-04

Brief Summary

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In this prospective observational multicenter study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10-day timeframe; determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote

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Detailed Description

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In this prospective multicenter observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Each participant will undego a oropharyngeal swab collection at day 0, day 5 and day 10 (or discharge), and a rectal swab at day 0 and day 10 or hospital discharge. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny, antimicrobial and chlorhexidine susceptibility. The primary endpoint is to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization. The secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10 days timeframe; to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote.

Conditions

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Oropharyngeal Gram-negative Bacilli Colonization

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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orthopedics (gr1) surgery

parient admitted to the orthopedics (gr1) surgery ward for an elective or semi-emergent surgical procedure.

No interventions assigned to this group

thoracic (gr2) surgery

parient admitted to the thoracic (gr2) surgery ward for an elective or semi-emergent surgical procedure.

No interventions assigned to this group

abdominal (gr3) surgery

parient admitted to the abdominal (gr3) surgery ward for an elective or semi-emergent surgical procedure.

No interventions assigned to this group

ICU (gr4)

patients admitted to the ICU with an antcipated length of stay of 3 days or more

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years old
* admitted in one of the participating surgery wards for elective or semi-emergent surgerical procedure or in one of the ICUs;
* for an anticipated length of stay of 72h