Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Completed

• Conditions: Oropharyngeal Gram-negative Bacilli Colonization

• Registration Number: NCT02839980
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Study Start: 2016-10-06
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of patients with a gram-negative colonization at admission	day 1	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.

Secondary Outcome Measures

Name	Time	Method
incidence of the acquisition of a oropharyngela or rectal GNB colonization	during hospital stay or 10 days if still hospitalized	incidence of the acquisition of a oropharyngela or rectal GNB colonization in the 4 populations
characterization of antimicrobial and chlorhexidine susceptibility of gram-negative isolates from oropharyngeal colonization	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
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

Trial Locations

Locations (1)

AP-HP, Louis Mourier Hospital; 🇫🇷 Colombes, Ile De France, France