Anti-Infective Agents, Urinary, Escherichia Coli Infections, Klebsiella Infections, Kidney Transplantation, Urinary Tract Infections
Conditions
Keywords
Extended-Spectrum ß-lactamase-producing Escherichia coli, Extended-Spectrum ß-lactamase-producing Klebsiella pneumoniae, Kidney Transplantation, Urinary Tract Infections
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.
Interventions
DRUGSitafloxacin
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.
DRUGErtapenem
Patients are given IV ertapenem for 14 days
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with clinical cure of acute urinary tract infection | 14 days | No symptoms of acute urinary tract infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Outcome results
None listed