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NCT Number: NCT02839980

Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

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

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Key information

Conditions

Oropharyngeal Gram-negative Bacilli Colonization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Louis Mourier Hospital

Colombes, Île-de-France Region, 92700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

proportion of patients with a gram-negative colonization at admission

Time frame: day 1

proportion 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 outcomes

incidence of the acquisition of a oropharyngela or rectal GNB colonization

Time frame: during hospital stay or 10 days if still hospitalized

incidence of the acquisition of a oropharyngela or rectal GNB colonization in the 4 populations
comparison of the predominant fecal flora with GNB oropharyngeal colonization

Time frame: hospital stay or 10 days if still hospitalized
characterization of antimicrobial and chlorhexidine susceptibility of gram-negative isolates from oropharyngeal colonization

Time frame: hospital stay or 10 days if still hospitalized
phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization

Time frame: hospital stay or 10 days if still hospitalized
comparision of the genetic identity of the dominant E. coli rectal and orpohayrngeal colonization with potential nosocomial infections

Time frame: hospital stay or 10 days if still hospitalized

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: OroColi

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jul 21, 2016
Registry last updated: Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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