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Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Hospital Subjects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02839980
Acronym
OroColi
Enrollment
399
Registered
2016-07-21
Start date
2016-10-06
Completion date
2018-07-04
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Gram-negative Bacilli Colonization

Keywords

oropharyngeal colonization

Brief summary

In this prospective observational multicenter study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10-day timeframe; determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote

Detailed description

In this prospective multicenter observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Each participant will undego a oropharyngeal swab collection at day 0, day 5 and day 10 (or discharge), and a rectal swab at day 0 and day 10 or hospital discharge. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny, antimicrobial and chlorhexidine susceptibility. The primary endpoint is to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization. The secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10 days timeframe; to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age \> 18 years old * admitted in one of the participating surgery wards for elective or semi-emergent surgerical procedure or in one of the ICUs; * for an anticipated length of stay of 72h

Exclusion criteria

* personal history of neck or face irradiation * bronchectasis; * patient's or proxies' opposition to participate

Design outcomes

Primary

MeasureTime frameDescription
proportion of patients with a gram-negative colonization at admissionday 1proportion of patients in whom admission oropahryngeal sample will contain at least one gram-negative bacilli among Haemophilus influenzae, an enterobacteria, or a non-fermenting GNB.

Secondary

MeasureTime frameDescription
incidence of the acquisition of a oropharyngela or rectal GNB colonizationduring hospital stay or 10 days if still hospitalizedincidence of the acquisition of a oropharyngela or rectal GNB colonization in the 4 populations
comparison of the predominant fecal flora with GNB oropharyngeal colonizationhospital stay or 10 days if still hospitalized
characterization of antimicrobial and chlorhexidine susceptibility of gram-negative isolates from oropharyngeal colonizationhospital stay or 10 days if still hospitalized
phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonizationhospital stay or 10 days if still hospitalized
comparision of the genetic identity of the dominant E. coli rectal and orpohayrngeal colonization with potential nosocomial infectionshospital stay or 10 days if still hospitalized

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026