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| Sponsored by: |
University Hospital, Clermont-Ferrand |
|---|---|
| Information provided by: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00621803 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Chu Clermont-Ferrand ( Christophe De Champs ) |
| Study ID Numbers: | CHU-0029, AFSSAPS 1220/CM/FE02 |
| Study First Received: | February 11, 2008 |
| Last Updated: | February 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00621803 History of Changes |
| Health Authority: | France: Ministry of Health |
|
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 |
|
Bacterial Infections Anti-Bacterial Agents Pseudomonas Infections Pneumonia Gram-Negative Bacterial Infections |
|
Bacterial Infections Pseudomonas Infections Infection Gram-Negative Bacterial Infections |
