Oropharyngeal Gram-negative Bacilli ColonizationOroColi-HSNCT02840656
Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization
An observational study of Oropharyngeal Gram-negative Bacilli Colonization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Gram-negative Bacilli Colonization
- What is being tested?
- oropharyngeal swabbing and rectal swabbing
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volonteers
Who may be able to join
- 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
Who cannot join
- affiliated to the social security
- The refusal of a patient to participate in a study
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Louis Mourier Hospital
Colombes, Île-de-France Region, 92700
About this study
Official title: Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects
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.
- Being tested
- oropharyngeal swabbing, rectal swabbing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oropharyngeal swabbingOther
microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done
rectal swabbingOther
same process as oropharyngeal swabbing will be used to collect rectal microbiological sample
| Study group | Role | What they receive |
|---|---|---|
| healthy adult subject | oropharyngeal and rectal swabbing to collect Gram-negative bacilli Receives: Other: oropharyngeal swabbing; Other: rectal swabbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with an oropharyngeal gram-negative colonization
Measured: Day 1
Secondary outcomes (4)
incidence of the a GNB oropharyngeal colonization
Measured: Day 1
comparision of the predominant fecal flora with GNB oropharyngeal colonization
Measured: Day 1
characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization
Measured: Day 1
phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion16 Aug 2017
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Gram-negative Bacilli ColonizationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan MESSIKA, MD, Principal investigator, Hopital Louis Mourier - Assistance Publique Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840656
- Sponsor's protocol ID
- P140907
- Acronym
- OroColi-HS
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2016
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects
- ClinicalTrials.gov ID
- NCT02840656
- Acronym / sponsor ID
- OroColi-HS / P140907
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy adult subject | – | Other: oropharyngeal swabbing, Other: rectal swabbingoropharyngeal and rectal swabbing to collect Gram-negative bacilli |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volonteers
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- affiliated to the social security
- The refusal of a patient to participate in a study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oropharyngeal swabbingmicrobiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done | Other | healthy adult subject |
| rectal swabbingsame process as oropharyngeal swabbing will be used to collect rectal microbiological sample | Other | healthy adult subject |
Primary outcome
proportion of patients with an oropharyngeal gram-negative colonization
Time frame: Day 1
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan MESSIKA, MD principal investigator
Hopital Louis Mourier - Assistance Publique Hopitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Gram-negative Bacilli Colonization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with an oropharyngeal gram-negative colonization (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.