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

Study Overview
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Brief Summary
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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
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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
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Anti-Infective Agents, Urinary, Escherichia Coli Infections, Klebsiella Infections, Kidney Transplantation, Urinary Tract Infections

Intervention / Treatment
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* Drug: Sitafloxacin
* Drug: Ertapenem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitafloxacin group<br>Sitafloxacin 100 mg oral twice daily | Drug: Sitafloxacin<br>* 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.<br>|
| Active Comparator: Ertapenem group<br>Ertapenem 1 gm IV every 24 h | Drug: Ertapenem<br>* Patients are given IV ertapenem for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with clinical cure of acute urinary tract infection | No symptoms of acute urinary tract infection | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with micrological cure of acute urinary tract infection | No evidence of Extended Spectrum Beta Lactamase Escherichia coli or Klebsiella pneumoniae in urine culture | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extended-Spectrum ß-lactamase-producing Escherichia coli, Extended-Spectrum ß-lactamase-producing Klebsiella pneumoniae, Kidney Transplantation, Urinary Tract Infections