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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

Primary Purpose

Anti-Infective Agents, Urinary, Escherichia Coli Infections, Klebsiella Infections

Status
Active
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Sitafloxacin
Ertapenem
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-Infective Agents, Urinary focused on measuring Extended-Spectrum ß-lactamase-producing Escherichia coli, Extended-Spectrum ß-lactamase-producing Klebsiella pneumoniae, Kidney Transplantation, Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Khon Kaen University
  • Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sitafloxacin group

Ertapenem group

Arm Description

Sitafloxacin 100 mg oral twice daily

Ertapenem 1 gm IV every 24 h

Outcomes

Primary Outcome Measures

Number of patients with clinical cure of acute urinary tract infection
No symptoms of acute urinary tract infection

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2016
Last Updated
March 7, 2023
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT02729116
Brief Title
Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Infective Agents, Urinary, Escherichia Coli Infections, Klebsiella Infections, Kidney Transplantation, Urinary Tract Infections
Keywords
Extended-Spectrum ß-lactamase-producing Escherichia coli, Extended-Spectrum ß-lactamase-producing Klebsiella pneumoniae, Kidney Transplantation, Urinary Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sitafloxacin group
Arm Type
Experimental
Arm Description
Sitafloxacin 100 mg oral twice daily
Arm Title
Ertapenem group
Arm Type
Active Comparator
Arm Description
Ertapenem 1 gm IV every 24 h
Intervention Type
Drug
Intervention Name(s)
Sitafloxacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Intervention Description
Patients are given IV ertapenem for 14 days
Primary Outcome Measure Information:
Title
Number of patients with clinical cure of acute urinary tract infection
Description
No symptoms of acute urinary tract infection
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of patients with micrological cure of acute urinary tract infection
Description
No evidence of Extended Spectrum Beta Lactamase Escherichia coli or Klebsiella pneumoniae in urine culture
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Khon Kaen University
City
Ban Khanaen
State/Province
Khonkaen
ZIP/Postal Code
40000
Country
Thailand
Facility Name
Khon Kaen University
City
Ban Khanaen
State/Province
Khonkaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
24772575
Citation
Thamlikitkul V, Tiengrim S. In vitro susceptibility test of sitafloxacin against resistant gram-negative bacilli isolated from Thai patients by disk diffusion method. J Med Assoc Thai. 2014 Mar;97 Suppl 3:S7-12.
Results Reference
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PubMed Identifier
24462425
Citation
Nakamura T, Komatsu M, Yamasaki K, Fukuda S, Higuchi T, Ono T, Nishio H, Sueyoshi N, Kida K, Satoh K, Toda H, Toyokawa M, Nishi I, Sakamoto M, Akagi M, Mizutani T, Nakai I, Kofuku T, Orita T, Zikimoto T, Natsume S, Wada Y. Susceptibility of various oral antibacterial agents against extended spectrum beta-lactamase producing Escherichia coli and Klebsiella pneumoniae. J Infect Chemother. 2014 Jan;20(1):48-51. doi: 10.1016/j.jiac.2013.08.004. Epub 2013 Dec 11.
Results Reference
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PubMed Identifier
22574524
Citation
Tiengrim S, Phiboonbanakit D, Thunyaharn S, Tantisiriwat W, Santiwatanakul S, Susaengrat W, Srisurat N, Malithong A, Srisangchan P, Thamlikitkul V. Comparative in vitro activity of sitafloxacin against bacteria isolated from Thai patients with urinary tract infections and lower respiratory tract infections. J Med Assoc Thai. 2012 Feb;95 Suppl 2:S6-17.
Results Reference
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Learn more about this trial

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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