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

Kidney Transplantation Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02729116
• Other study ID #: HE581520
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2016
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anti-Infective Agents, Urinary
• Communicable Diseases
• Escherichia coli Infections
• Infections
• Kidney Transplantation
• Klebsiella Infections
• Urinary Tract Infections

Intervention

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.
• Ertapenem
Patients are given IV ertapenem for 14 days

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Ban Khanaen	Khonkaen
Thailand	Khon Kaen University	Ban Khanaen	Khonkaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with clinical cure of acute urinary tract infection	No symptoms of acute urinary tract infection	14 days
Secondary	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