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Lcr35 / ICU / P. Aeruginosa

Primary Purpose

Pseudomonas Infections

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic Lactobacillus casei rhamnosus (Lcr35)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudomonas Infections focused on measuring Probiotic, Pseudomonas aeruginosa, Gastric colonization, Respiratory tract colonization, Ventilator aquired pneumoniae, determine the effect of oral administration of this probiotic on gastric and respiratory tract colonisation/infection by P. aeruginosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • more than 18 years old
  • length of stay longer than 48h
  • with a nasogastric feeding tube

Exclusion Criteria:

  • - less than 18 years old
  • length of stay < 48h
  • immunosuppression
  • absolute neutrophile count < 500/mm3
  • gastro-intestinal bleeding
  • contraindicated enteral feeding
  • positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Delay in P.aeruginosa colonisation

    Secondary Outcome Measures

    Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach

    Full Information

    First Posted
    February 11, 2008
    Last Updated
    February 21, 2008
    Sponsor
    University Hospital, Clermont-Ferrand
    Collaborators
    Université d'Auvergne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00621803
    Brief Title
    Lcr35 / ICU / P. Aeruginosa
    Official Title
    Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Terminated
    Why Stopped
    Recruiting or enrolling participants has halted and will not resume
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    October 2004 (Anticipated)
    Study Completion Date
    October 2005 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Clermont-Ferrand
    Collaborators
    Université d'Auvergne

    4. Oversight

    5. Study Description

    Brief Summary
    Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.
    Detailed Description
    In this prospective double-blind randomised study, ICU patients receive twice a day either an oral dose of Lactobacillus casei rhamnosus, the available pharmaceutical form, or a placebo. Digestive tract carriage of Pseudomonas aeruginosa is monitored by cultures of gastric aspirates. The occurrence of respiratory tract colonisations / infections is monitored throughout the study. Evaluation criteria are the delay and the rates of gastric P. aeruginosa colonisation and respiratory tract infection or colonisation. Chi-square or two tailed Fisher exact test are used for comparing qualitative variables and Student's t-test or mann-Whitney test for quantitatives variables. The mean of non-acquisition expectancy (NAE), length of stay without P. aeruginosa acquisition, was calculated and P. aeruginosa non-colonized patient rates were estimated and the two groups compared with regard to survival curves from grouped data using the Kaplan Meier method and the Logrank test. Variables with a P. value ≤0.15 in the univariate analysis were included in a logistic regression and a Cox regression model for multivariate analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pseudomonas Infections
    Keywords
    Probiotic, Pseudomonas aeruginosa, Gastric colonization, Respiratory tract colonization, Ventilator aquired pneumoniae, determine the effect of oral administration of this probiotic on gastric and respiratory tract colonisation/infection by P. aeruginosa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Probiotic Lactobacillus casei rhamnosus (Lcr35)
    Primary Outcome Measure Information:
    Title
    Delay in P.aeruginosa colonisation
    Secondary Outcome Measure Information:
    Title
    Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: more than 18 years old length of stay longer than 48h with a nasogastric feeding tube Exclusion Criteria: - less than 18 years old length of stay < 48h immunosuppression absolute neutrophile count < 500/mm3 gastro-intestinal bleeding contraindicated enteral feeding positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christophe De Champs, MD PhD
    Organizational Affiliation
    University Hospital, Clermont-Ferrand
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Lcr35 / ICU / P. Aeruginosa

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