OroColi-HS: Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT02840656

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Gram-negative Bacilli Colonization	Other: oropharyngeal swabbing Other: rectal swabbing

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

Actual Enrollment :

100 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Aug 16, 2017

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
healthy adult subject oropharyngeal and rectal swabbing to collect Gram-negative bacilli	Other: oropharyngeal swabbing microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done Other: rectal swabbing same process as oropharyngeal swabbing will be used to collect rectal microbiological sample

Arm

Intervention/Treatment

healthy adult subject

oropharyngeal and rectal swabbing to collect Gram-negative bacilli

Other: oropharyngeal swabbing

microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done

Other: rectal swabbing

same process as oropharyngeal swabbing will be used to collect rectal microbiological sample

Outcome Measures

Primary Outcome Measures

proportion of patients with an oropharyngeal gram-negative colonization [Day 1]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Louis Mourier Hospital	Colombes	Ile De France	France	92700

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT02840656

Other Study ID Numbers:

P140907

First Posted:

Jul 21, 2016

Last Update Posted:

Jul 9, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Study Results

No Results Posted as of Jul 9, 2020