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Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization (OroColi)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Oropharyngeal Gram-negative Bacilli Colonization

Study type

Observational

Funder types

Other

Identifiers

NCT02839980
NI15006

Details and patient eligibility

About

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

Full 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.

Enrollment

399 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

399 participants in 4 patient groups

orthopedics (gr1) surgery
Description:
parient admitted to the orthopedics (gr1) surgery ward for an elective or semi-emergent surgical procedure.
thoracic (gr2) surgery
Description:
parient admitted to the thoracic (gr2) surgery ward for an elective or semi-emergent surgical procedure.
abdominal (gr3) surgery
Description:
parient admitted to the abdominal (gr3) surgery ward for an elective or semi-emergent surgical procedure.
ICU (gr4)
Description:
patients admitted to the ICU with an antcipated length of stay of 3 days or more

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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