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

Khon Kaen University

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Urinary Tract Infections; Anti-Infective Agents, Urinary; Escherichia Coli Infections; Kidney Transplantation; Klebsiella Infections

Treatments: Drug: Sitafloxacin; Drug: Ertapenem

Study type: Interventional

Funder types: Other

Identifiers

NCT02729116

HE581520

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Sitafloxacin group

Experimental group

Description:

Sitafloxacin 100 mg oral twice daily

Treatment:

Drug: Sitafloxacin

Ertapenem group

Active Comparator group

Description:

Ertapenem 1 gm IV every 24 h

Treatment:

Drug: Ertapenem