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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 : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : July 9, 2020
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.

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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 : September 2016
Actual Primary Completion Date : August 16, 2017
Estimated Study Completion Date : November 2020

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 ]


Information from the National Library of Medicine

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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


Locations
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France
AP-HP, Louis Mourier Hospital
Colombes, Ile De France, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jonathan MESSIKA, MD Hopital Louis Mourier - Assistance Publique Hopitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02840656    
Other Study ID Numbers: P140907
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided