Colonization by multiresistant enterobacteria in patients who underwent liver and renal transplants
Conditions
Interventions
Trade Name: Neomicina SALVAT
Product Name: Neomycin sulfate
Product Code: 8378
Pharmaceutical Form: Tablet
INN or Proposed INN: NEOMYCIN SULFATE
CAS Number: 1404-04-2
Current Sponsor code: NEOMYCIN SU
Sponsors
Mª Carmen Fariñas Álvarez. Hospital Universitario Marques de Valdecilla
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients undergoing a liver or kidney transplants in the participating hospitals with a multiresistant enterobacteria positive rectal swab previous to transplant, during the study period, and sign the informed consent. 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 158 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Patients aged 2mg/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether treatment with colistin and neomycin orally for 14 days in patients with kidney and liver transplants with colonization by ESBL-producing enterobacteriaceae with chromosomal or plasmid AmpC or carbapenemases, reduces infections by these microorganisms, in the first 30 days after transplantation.;Secondary Objective: 1. To evaluate the treatment efficiency with oral colistin and neomycin during 14 days, in reducing the infections 1 month after treatment, in patients colonized with multiresistant enterobacteria before the transplantation (<48h). 2. To determine the security of treatment of oral colistin and neomycin during 14 days in the appearance of adverse side effects and resistance in colonized patients with multiresistant enterobacteria before the transplantation (<48h).;Primary end point(s): Infection diagnosis by multiresistant enterobacterias.;Timepoint(s) of evaluation of this end point: Monitoring up to 45 days after transplantation: weekly until the month after the transplantation and one last visit the 45 days after transplantation (1 month after treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Detection in swab of intestinal colonization by multiresistant enterobacteria during the monitoring. Changes in the colistin MIC between basal swab and that one in the last visit. Security and tolerability of the decolonized treatment studied.;Timepoint(s) of evaluation of this end point: Monitoring up to 45 days after transplantation: weekly until the month after the transplantation and one last visit the 45 days after transplantation (1 month after treatment). | — |
Countries
Spain
Contacts
Public ContactInfectious Diseases Unit
Mª Carmen Fariñas Álvarez. Hospital Universitario Marqués de Valdecilla
Outcome results
None listed