Clinical Trial: A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation

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

Official Title: A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation

Brief Summary: The major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation.

Detailed Summary:

Introduction: Treatment of asymptomatic bacteriuria is a common practice in renal transplant centers leading to prolong exposure of antimicrobial agents with long hospital length of stay. The duration of antibiotics treatment in this condition have never been proposed.

Objective: To evaluate the proper duration of antibiotic treatment for asymptomatic bacteriuria early (less than 1 month) after kidney transplantation

Method: This is a prospective, randomized, open labeled, single center study using intention to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive 7 or 14 days course of antibiotics.


Sponsor: Mahidol University

Current Primary Outcome: Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate [ Time Frame: 1 month ]

Composite end point at 1 month after discontinuing antibiotics


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate [ Time Frame: 0.5 months ]
    Composite end point at 0.5 months after discontinuing antibiotics
  • Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and [ Time Frame: 3 months ]
    Composite end point at 3 months after discontinuing antibiotics
  • duration of hospital stay [ Time Frame: 30 days since randomization ]
    duration of hospital stay


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: October 8, 2015
Date Started: February 2015
Date Completion:
Last Updated: March 15, 2016
Last Verified: March 2016