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
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
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
NCT ID
NCT00621803
First Posted
February 11, 2008
Last Updated
February 21, 2008
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne
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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