Clinical trial NCT02840656: Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization
Official title: Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Gram-negative Bacilli Colonization
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volonteers

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of patients with an oropharyngeal gram-negative colonization
timeFrame: Day 1
Secondary outcomes:
measure: incidence of the a GNB oropharyngeal colonization
timeFrame: Day 1
measure: comparision of the predominant fecal flora with GNB oropharyngeal colonization
timeFrame: Day 1
measure: characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization
timeFrame: Day 1
measure: phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization
timeFrame: Day 1
Other outcomes:
Locations:
city: Colombes
country: France
facility: AP-HP, Louis Mourier Hospital
state: Ile De France
Study officials:
affiliation: Hopital Louis Mourier - Assistance Publique Hopitaux de Paris
name: Jonathan MESSIKA, MD
role: PRINCIPAL_INVESTIGATOR
References: