NCT02729116

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Anti-Infective Agents, Urinary
• Escherichia Coli Infections
• Klebsiella Infections
• Kidney Transplantation
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Sitafloxacin	Patients are given intravenous empirical antibiotics for 3 days. The patients are allocated to the sitafloxacin group or ertapenem group using of a computer-generated random number allocation schedule and block size of four.
DRUG	Ertapenem	Patients are given IV ertapenem for 14 days

Timeline

• Start date: 2016-07-01
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2016-04-06
• Last updated: 2023-03-08

Locations

2 sites across 1 country: Thailand