Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Oropharyngeal Gram-negative Bacilli Colonization Clinical Trial

— OroColi-HS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840656
• Other study ID #: P140907
• Status: Completed
• Start date: September 2016
• Est. completion date: November 2020

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2020
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Gram-negative Bacilli Colonization

Intervention

Other:
• oropharyngeal swabbing
microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done
• rectal swabbing
same process as oropharyngeal swabbing will be used to collect rectal microbiological sample

Locations

Country	Name	City	State
France	AP-HP, Louis Mourier Hospital	Colombes	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with an oropharyngeal gram-negative colonization		Day 1
Secondary	incidence of the a GNB oropharyngeal colonization		Day 1
Secondary	comparision of the predominant fecal flora with GNB oropharyngeal colonization		Day 1
Secondary	characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization		Day 1
Secondary	phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization		Day 1