Clinical Trial: Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.

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

Detailed Summary:

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.


Sponsor: Núria Sabé Fernàndez

Current Primary Outcome: To determine the incidence of pyelonephritis in both groups [ Time Frame: First year after kidney transplantation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Renal function [ Time Frame: First year after kydney transplantation ]
  • Need for hospitalization [ Time Frame: First year after kydney transplantation ]
  • Incidence of graft loss [ Time Frame: First year after kidney transplantation ]
  • Mortality [ Time Frame: First year after kidney transplantation ]


Original Secondary Outcome: Same as current

Information By: Hospital Universitari de Bellvitge

Dates:
Date Received: December 21, 2012
Date Started: January 2013
Date Completion: December 2015
Last Updated: June 19, 2015
Last Verified: June 2015