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CompletedNCT02840656OroColi-HSUpdated Jun 12, 2023

Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

An observational study in Oropharyngeal Gram-negative Bacilli Colonization, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Oropharyngeal Gram-negative Bacilli Colonization
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In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,578 studies on the registry; 1,030 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

healthy volonteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • affiliated to the social security
  • The refusal of a patient to participate in a study
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • healthy adult subject

    oropharyngeal and rectal swabbing to collect Gram-negative bacilli

    Other: oropharyngeal swabbing · Other: rectal swabbing

Interventions

  • Otheroropharyngeal swabbing

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

  • Otherrectal swabbing

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

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What researchers measure

Primary outcomes

  1. proportion of patients with an oropharyngeal gram-negative colonization

    Time frame: Day 1

Secondary outcomes

  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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Study locations

1 site
  • AP-HP, Louis Mourier Hospital
    Colombes, Île-de-France Region 92700, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02840656
Responsible party
Sponsor
First posted
Jul 21, 2016
Start date
Sep 2016
Primary completion
Aug 16, 2017
Completion
Nov 2020
Last update
Jun 12, 2023

Study contacts

Jonathan MESSIKA, MD
principal investigator · Hopital Louis Mourier - Assistance Publique Hopitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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