Clinical trial NCT02839980: Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization
Official title: Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Hospital Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Gram-negative Bacilli Colonization
Keywords: oropharyngeal colonization
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted in wards in which emergence of multi-drug resistant bacteria justifies a regular monitoring (i.e. surgical wards and ICU)

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of patients with a gram-negative colonization at admission
timeFrame: day 1
Secondary outcomes:
measure: incidence of the acquisition of a oropharyngela or rectal GNB colonization
timeFrame: during hospital stay or 10 days if still hospitalized
measure: comparison of the predominant fecal flora with GNB oropharyngeal colonization
timeFrame: hospital stay or 10 days if still hospitalized
measure: characterization of antimicrobial and chlorhexidine susceptibility of gram-negative isolates from oropharyngeal colonization
timeFrame: hospital stay or 10 days if still hospitalized
measure: phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization
timeFrame: hospital stay or 10 days if still hospitalized
measure: comparision of the genetic identity of the dominant E. coli rectal and orpohayrngeal colonization with potential nosocomial infections
timeFrame: hospital stay or 10 days if still hospitalized
Other outcomes:
Locations:
city: Colombes
country: France
facility: AP-HP, Louis Mourier Hospital
state: Ile De France
Study officials:
affiliation: Hopital Louis Mourier - Assistance Publique Hopitaux de Paris
name: Jonathan MESSIKA, MD,
role: PRINCIPAL_INVESTIGATOR
References: