Clinical Trial: Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli

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

Official Title: A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli

Brief Summary: The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial agents which can be used in outpatient for the treatment of non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was conducted to compare the clinical and bacteriological outcomes of patients with non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV ertapenem.

Detailed Summary: A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis caused by Extended Spectrum Beta Lactamase-producing pathogen was performed. Carbapenems was initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The regular course of treatment was completed within 10 days.
Sponsor: Mahidol University

Current Primary Outcome: no symptoms of urinary tract infection [ Time Frame: 30 days ]

no fever, dysuria, back pain, nausea and vomiting


Original Primary Outcome: Same as current

Current Secondary Outcome: no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture [ Time Frame: 30 days ]

Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: August 2, 2015
Date Started: November 2012
Date Completion: May 2016
Last Updated: August 28, 2015
Last Verified: August 2015