Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Oropharyngeal Gram-negative Bacilli Colonization Clinical Trial

— OroColi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839980
• Other study ID #: NI15006
• Status: Completed
• Start date: October 6, 2016
• Est. completion date: July 4, 2018

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Gram-negative Bacilli Colonization

Locations

Country	Name	City	State
France	AP-HP, Louis Mourier Hospital	Colombes	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with a gram-negative colonization at admission	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.	day 1
Secondary	incidence of the acquisition of a oropharyngela or rectal GNB colonization	incidence of the acquisition of a oropharyngela or rectal GNB colonization in the 4 populations	during hospital stay or 10 days if still hospitalized
Secondary	comparison of the predominant fecal flora with GNB oropharyngeal colonization		hospital stay or 10 days if still hospitalized
Secondary	characterization of antimicrobial and chlorhexidine susceptibility of gram-negative isolates from oropharyngeal colonization		hospital stay or 10 days if still hospitalized
Secondary	phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization		hospital stay or 10 days if still hospitalized
Secondary	comparision of the genetic identity of the dominant E. coli rectal and orpohayrngeal colonization with potential nosocomial infections		hospital stay or 10 days if still hospitalized