Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Study Overview
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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

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.

Official Title
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Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Hospital Subjects

Conditions
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Oropharyngeal Gram-negative Bacilli Colonization

Participation Criteria
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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 Exclusion Criteria: personal history of neck or face irradiation bronchectasis; patient's or proxies' opposition to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| orthopedics (gr1) surgery<br>parient admitted to the orthopedics (gr1) surgery ward for an elective or semi-emergent surgical procedure. | |
| thoracic (gr2) surgery<br>parient admitted to the thoracic (gr2) surgery ward for an elective or semi-emergent surgical procedure. | |
| abdominal (gr3) surgery<br>parient admitted to the abdominal (gr3) surgery ward for an elective or semi-emergent surgical procedure. | |
| ICU (gr4)<br>patients admitted to the ICU with an antcipated length of stay of 3 days or more | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with a gram-negative colonization at admission | proportion of patients in whom admission oropahryngeal sample will contain at least one gram-negative bacilli among Haemophilus influenzae, an enterobacteria, or a non-fermenting GNB. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of the acquisition of a oropharyngela or rectal GNB colonization | incidence of the acquisition of a oropharyngela or rectal GNB colonization in the 4 populations | during hospital stay or 10 days if still hospitalized | 
| comparison of the predominant fecal flora with GNB oropharyngeal colonization |  | hospital stay or 10 days if still hospitalized | 
| characterization of antimicrobial and chlorhexidine susceptibility of gram-negative isolates from oropharyngeal colonization |  | hospital stay or 10 days if still hospitalized | 
| phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization |  | hospital stay or 10 days if still hospitalized | 
| comparision of the genetic identity of the dominant E. coli rectal and orpohayrngeal colonization with potential nosocomial infections |  | hospital stay or 10 days if still hospitalized | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oropharyngeal colonization