Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

NCT ID: NCT02840656

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Oropharyngeal Gram-negative Bacilli Colonization

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy adult subject

oropharyngeal and rectal swabbing to collect Gram-negative bacilli

oropharyngeal swabbing

Intervention Type OTHER

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

rectal swabbing

Intervention Type OTHER

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

Interventions

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oropharyngeal swabbing

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

Intervention Type OTHER

rectal swabbing

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan MESSIKA, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Louis Mourier - Assistance Publique Hopitaux de Paris

Locations

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AP-HP, Louis Mourier Hospital

Colombes, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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P140907

Identifier Type: -

Identifier Source: org_study_id

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