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

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ClinicalTrials.gov Identifier: NCT02840656
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
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 Type : Observational
Estimated 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 : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019


Group/Cohort 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




Primary Outcome Measures :
  1. proportion of patients with an oropharyngeal gram-negative colonization [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. incidence of the a GNB oropharyngeal colonization [ Time Frame: Day 1 ]
  2. comparision of the predominant fecal flora with GNB oropharyngeal colonization [ Time Frame: Day 1 ]
  3. characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization [ Time Frame: Day 1 ]
  4. phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy volonteers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840656


Contacts
Contact: Jonathan MESSIKA, MD +331 47 60 63 29 jonathan.messika@aphp.fr
Contact: Jean-Damien RICARD, MD, Ph D +331 47 60 61 91 jean-damien.ricard@aphp.fr

Locations
France
AP-HP, Louis Mourier Hospital Recruiting
Colombes, Ile De France, France, 92700
Contact: jonathan MESSIKA, MD       jonathan.messika@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jonathan MESSIKA, MD Hopital Louis Mourier - Assistance Publique Hopitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02840656     History of Changes
Other Study ID Numbers: P140907
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents