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

Phase 2

Active, not recruiting

• Conditions: Escherichia Coli Infections; Kidney Transplantation; Anti-Infective Agents, Urinary; Klebsiella Infections; Urinary Tract Infections
• Interventions: Drug: Ertapenem; Drug: Sitafloxacin

• Registration Number: NCT02729116
• Lead Sponsor: Khon Kaen University

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 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.

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Study Start: 2016-07
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age >18 years
• Acute urinary infection by definitions
• Positive urine culture for Extended Spectrum Beta Lactamase E. coli or K. pneumoniae ≥105 colony forming unit/mL
• Post-kidney transplantation
• Voluntarily consented to be enrolled in the study

Exclusion Criteria

• Sepsis
• Positive blood culture
• Mixed organism of urine culture
• Immunocompromised conditions other than post-kidney transplantation
• Pregnancy or lactation
• Previous urinary tract infections within 4 weeks
• Contraindicated for fluoroquinolones and carbapenems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ertapenem group	Ertapenem	Ertapenem 1 gm IV every 24 h
Sitafloxacin group	Sitafloxacin	Sitafloxacin 100 mg oral twice daily

Primary Outcome Measures

Name	Time	Method
Number of patients with clinical cure of acute urinary tract infection	14 days	No symptoms of acute urinary tract infection

Secondary Outcome Measures

Name	Time	Method
Number of patients with micrological cure of acute urinary tract infection	14 days	No evidence of Extended Spectrum Beta Lactamase Escherichia coli or Klebsiella pneumoniae in urine culture

Trial Locations

Locations (1)

Khon Kaen University; 🇹🇭 Ban Khanaen, Khonkaen, Thailand