Overview

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

Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Khon Kaen University
Treatments:
Ertapenem
Fluoroquinolones
Sitafloxacin
Criteria
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