Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Completed

• Conditions: Oropharyngeal Gram-negative Bacilli Colonization
• Interventions: Other: oropharyngeal swabbing; Other: rectal swabbing

• Registration Number: NCT02840656
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal of predominant GNB colonization.

Detailed Description

In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 100 healthy subjects, and their susceptibility to chlorehexidine. Each participant will undego a oropharyngeal swab collection and a rectal swab at day 0. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny; gram-negative isolates will be studied in terms of antimicrobial and chlorhexidine susceptibility. The primary objective is to determine the prevalence of oropharyngeal Gram-negative bacilli colonization. The secondary objectives are to determine the chlorhexidine and antimicrobial susceptibility of such colonization; to determine the phylogentic characteristics of oropharyngeal and rectal predominant E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates.

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Study Start: 2016-09
• Primary Completion: 2017-08-16
• Study Completion: 2020-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age > 18 yo
• personal history of neck or face irradiation
• no history of gastrointestinal disease
• no symptoms of immunosuppression
• no antibiotic therapy in the previous month
• no hospitalization in the 3 months preceding inclusion
• medical exmination prior to inclusion

Exclusion Criteria

• affiliated to the social security
• The refusal of a patient to participate in a study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy adult subject	oropharyngeal swabbing	oropharyngeal and rectal swabbing to collect Gram-negative bacilli
healthy adult subject	rectal swabbing	oropharyngeal and rectal swabbing to collect Gram-negative bacilli

Primary Outcome Measures

Name	Time	Method
proportion of patients with an oropharyngeal gram-negative colonization	Day 1

Secondary Outcome Measures

Name	Time	Method
characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization	Day 1
comparision of the predominant fecal flora with GNB oropharyngeal colonization	Day 1
phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization	Day 1
incidence of the a GNB oropharyngeal colonization	Day 1

Trial Locations

Locations (1)

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