Clinical Trial: Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic P

Brief Summary: Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.

Detailed Summary: All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.
Sponsor: López-Medrano, Francisco, M.D.

Current Primary Outcome: Incidence of Pyelonephritis [ Time Frame: 2 years after transplantation ]

The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of lower tract urinary infection [ Time Frame: 2 years after transplantation ]
    The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
  • Incidence of Clostridium difficile infection [ Time Frame: 2 years after transplantation ]
    The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
  • Incidence of multidrug resistant bacteria colonization/infection [ Time Frame: 2 years after transplantation ]
    The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
  • Long-term graft function [ Time Frame: At 1 year and 2 years after transplantation ]
    Long-term graft function measured by average serum creatinine at several points until the end of follow-up.


Original Secondary Outcome: Same as current

Information By: López-Medrano, Francisco, M.D.

Dates:
Date Received: February 13, 2015
Date Started: January 2011
Date Completion:
Last Updated: February 20, 2015
Last Verified: February 2015