Lcr35 / ICU / P. Aeruginosa
February 21, 2008 updated by: University Hospital, Clermont-Ferrand
Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Delay in P.aeruginosa colonisation
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Secondary Outcome Measures
Outcome Measure |
|---|
|
Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christophe De Champs, MD PhD, University Hospital, Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Anticipated)
October 1, 2004
Study Completion (Anticipated)
October 1, 2005
Study Registration Dates
First Submitted
February 11, 2008
First Submitted That Met QC Criteria
February 21, 2008
First Posted (Estimate)
February 22, 2008
Study Record Updates
Last Update Posted (Estimate)
February 22, 2008
Last Update Submitted That Met QC Criteria
February 21, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0029
- AFSSAPS 1220/CM/FE02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.