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

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ClinicalTrials.gov Identifier: NCT02729116
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Atibordee Meesing, MD, 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.

Condition or disease Intervention/treatment Phase
Anti-Infective Agents, Urinary Escherichia Coli Infections Klebsiella Infections Kidney Transplantation Urinary Tract Infections Drug: Sitafloxacin Drug: Ertapenem Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: Sitafloxacin group
Sitafloxacin 100 mg oral twice daily
Drug: Sitafloxacin
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.

Active Comparator: Ertapenem group
Ertapenem 1 gm IV every 24 h
Drug: Ertapenem
Patients are given IV ertapenem for 14 days




Primary Outcome Measures :
  1. Number of patients with clinical cure of acute urinary tract infection [ Time Frame: 14 days ]
    No symptoms of acute urinary tract infection


Secondary Outcome Measures :
  1. Number of patients with micrological cure of acute urinary tract infection [ Time Frame: 14 days ]
    No evidence of Extended Spectrum Beta Lactamase Escherichia coli or Klebsiella pneumoniae in urine culture



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729116


Contacts
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Contact: Atibordee Meesing, M.D. +66898422698 atibordee@kku.ac.th
Contact: Pantipa Tonsawan, M.D. +66850075754 tonpantipa@hotmail.com

Locations
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Thailand
Khon Kaen University Recruiting
Ban Khanaen, Khonkaen, Thailand, 40000
Contact: Atibordee Meesing    +668422698    atibordee@kku.ac.th   
Khon Kaen University Recruiting
Ban Khanaen, Khonkaen, Thailand, 40002
Contact: Atibordee Meesing, M.D.    +66898422698    atibordee@kku.ac.th   
Contact: Pantipa Tonsawan, M.D.    +66850075754    tonpantipa@hotmail.com   
Sponsors and Collaborators
Khon Kaen University

Publications:
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Responsible Party: Atibordee Meesing, MD, Principal Investigator, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02729116     History of Changes
Other Study ID Numbers: HE581520
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Keywords provided by Atibordee Meesing, MD, Khon Kaen University:
Extended-Spectrum ß-lactamase-producing Escherichia coli
Extended-Spectrum ß-lactamase-producing Klebsiella pneumoniae
Kidney Transplantation
Urinary Tract Infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Klebsiella Infections
Escherichia coli Infections
Urologic Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Ertapenem
Sitafloxacin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors