Clinical Trial: Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients

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

Official Title:

Brief Summary: This study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute urinary tract infection caused by Extended Spectrum Beta Lactamase producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Patients are treated with intravenous (IV) antibiotics follow by oral sitafloxacin or IV ertapenem.

Detailed Summary: A prospective randomized controlled trial of patients with a presumptive diagnosis of acute urinary tract infection caused by Extended Spectrum Beta Lactamase-producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Intravenous (IV) antibiotic is initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The course of treatment will complete within 14 days.
Sponsor: Khon Kaen University

Current Primary Outcome: Number of patients with clinical cure of acute urinary tract infection [ Time Frame: 14 days ]

No symptoms of acute urinary tract infection


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of patients with micrological cure of acute urinary tract infection [ Time Frame: 14 days ]

No evidence of Extended Spectrum Beta Lactamase Escherichia coli or Klebsiella pneumoniae in urine culture


Original Secondary Outcome: Same as current

Information By: Khon Kaen University

Dates:
Date Received: March 24, 2016
Date Started: March 2016
Date Completion: January 2017
Last Updated: March 31, 2016
Last Verified: March 2016