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