Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria (BAC01)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Hospital Universitari de Bellvitge
Sponsor:
Information provided by (Responsible Party):
Núria Sabé Fernàndez, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01771432
First received: December 21, 2012
Last updated: January 16, 2013
Last verified: December 2012

December 21, 2012
January 16, 2013
January 2013
December 2013   (final data collection date for primary outcome measure)
To determine the incidence of pyelonephritis in both groups [ Time Frame: First year after kidney transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01771432 on ClinicalTrials.gov Archive Site
  • Renal function [ Time Frame: First year after kydney transplantation ] [ Designated as safety issue: Yes ]
  • Need for hospitalization [ Time Frame: First year after kydney transplantation ] [ Designated as safety issue: Yes ]
  • Incidence of graft loss [ Time Frame: First year after kidney transplantation ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: First year after kidney transplantation ] [ Designated as safety issue: Yes ]
Same as current
Infection by multiresistant microorganisms [ Time Frame: First year after kydney transplantation ] [ Designated as safety issue: No ]
Same as current
 
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.

Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.

Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.

Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.

Primary end points: To determine in both groups: the incidence of pyelonephritis.

Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Asymptomatic Bacteriuria
  • Pyelonephritis
  • Drug: Antibiotic treatment
    Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
  • Other: No treatment
    Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
  • Active Comparator: Antibiotic treatment
    Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
    Intervention: Drug: Antibiotic treatment
  • No treatment
    Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
    Intervention: Other: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who receive a transplant allograft during study period

Exclusion Criteria:

  • No acceptation of study
Both
18 Years to 85 Years
No
Contact: Núria Sabé Fernàndez +932607625 nfsabe@bellvitgehospital.cat
Spain
 
NCT01771432
FIS11-1540
Yes
Núria Sabé Fernàndez, Hospital Universitari de Bellvitge
Núria Sabé Fernàndez
Not Provided
Principal Investigator: Núria Sabé Fernàndez Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP