Clinical trial NCT00621803: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Université d'Auvergne
First posted: 2008-02-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Delay in P.aeruginosa colonisation
Secondary outcomes:
measure: Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Christophe De Champs, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: