Intestinal colonisation with multiresistant bacteria MedDRA version: 14.1 Level: LLT Classification code 10069719 Term: Bacterial colonisation System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Antibiophilus
Product Name: Antibiophilus
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: LCR35
CAS Number: L04001-00-0
Other descriptive name: LACTOBACILLUS RHAMNOSUS
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Stool culture positive for ESBL producing Enterobacteriacea or vancomycin resistant enterococci Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: a) Immunosuppression b) Transplanted patients c) Neutropenic patients d) Patients who received biological medication, especially TNF-a inhibitors, in the past twelve months prior to inclusion e) Known pregnancy f) allergy to milk protein g) Other reasons opposing the study participation on the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Removal of multi resistant bacteria from the intestine;Secondary Objective: Time to stool culture negativity;Primary end point(s): Stool culture negativity;Timepoint(s) of evaluation of this end point: day 14, 21, 28, 35, 42, 49, 56 and 63 of the individual patients treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to negativity of the stool culture;Timepoint(s) of evaluation of this end point: day 14, 21, 28, 35, 42, 49, 56 and 63 of the individual patients treatment period | — |
Countries
Austria
Contacts
Public ContactFlorian Thalhammer
Medical University of Vienna
Outcome results
None listed