Lcr35 / ICU / P. Aeruginosa

This study has been terminated.
(Recruiting or enrolling participants has halted and will not resume)
Sponsor:
Collaborator:
University Auvergne, Clermont-Ferrand
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00621803
First received: February 11, 2008
Last updated: February 21, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention
Pseudomonas Infections
Drug: Probiotic Lactobacillus casei rhamnosus (Lcr35)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

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

Enrollment: 400
Study Start Date: March 2003
Estimated Study Completion Date: October 2005
Estimated Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00621803

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Auvergne, Clermont-Ferrand
Investigators
Principal Investigator: Christophe De Champs, MD PhD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Christophe De Champs, Chu Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00621803     History of Changes
Other Study ID Numbers: CHU-0029, AFSSAPS 1220/CM/FE02
Study First Received: February 11, 2008
Last Updated: February 21, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
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

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 22, 2014