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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 19, 2016
First Posted Date July 21, 2016
Last Update Posted Date July 9, 2020
Study Start Date September 2016
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2016)
proportion of patients with an oropharyngeal gram-negative colonization [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 20, 2016)
  • incidence of the a GNB oropharyngeal colonization [ Time Frame: Day 1 ]
  • comparision of the predominant fecal flora with GNB oropharyngeal colonization [ Time Frame: Day 1 ]
  • characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization [ Time Frame: Day 1 ]
  • phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization [ Time Frame: Day 1 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization
Official Title Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects
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.
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
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population healthy volonteers
Condition 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
  • Other: rectal swabbing
    same process as oropharyngeal swabbing will be used to collect rectal microbiological sample
Study Groups/Cohorts healthy adult subject
oropharyngeal and rectal swabbing to collect Gram-negative bacilli
Interventions:
  • Other: oropharyngeal swabbing
  • Other: rectal swabbing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 20, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2020
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02840656
Other Study ID Numbers P140907
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Jonathan MESSIKA, MD Hopital Louis Mourier - Assistance Publique Hopitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2020