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Clinical Trials/NCT02840656
NCT02840656CompletedNot Applicable

Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects

Assistance Publique - Hôpitaux de Paris1 site in 1 country100 target enrollmentStarted: September 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
proportion of patients with an oropharyngeal gram-negative colonization

Study Overview

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 Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

proportion of patients with an oropharyngeal gram-negative colonization

Time Frame: Day 1

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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