Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization (OroColi)

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

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

Study Overview

• Status: Completed
• Conditions: Oropharyngeal Gram-negative Bacilli Colonization

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 399

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Colombes, Ile De France, France, 92700
      • AP-HP, Louis Mourier Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted in wards in which emergence of multi-drug resistant bacteria justifies a regular monitoring (i.e. surgical wards and ICU)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
orthopedics (gr1) surgery; parient admitted to the orthopedics (gr1) surgery ward for an elective or semi-emergent surgical procedure.
thoracic (gr2) surgery; parient admitted to the thoracic (gr2) surgery ward for an elective or semi-emergent surgical procedure.
abdominal (gr3) surgery; parient admitted to the abdominal (gr3) surgery ward for an elective or semi-emergent surgical procedure.
ICU (gr4); patients admitted to the ICU with an antcipated length of stay of 3 days or more

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jonathan MESSIKA, MD,, Hopital Louis Mourier - Assistance Publique Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2016
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): July 4, 2018

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimated): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: oropharyngeal colonization
• Other Study ID Numbers: NI15006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED