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NCT02729116 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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